Heart Surgical ProcedureNCT06009809
Blood Velocity Variation in Right Renal and Superior Mesenteric Arteries During Cardio-pulmonary Bypass
An observational study of Heart Surgical Procedure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgical Procedure
- What is being tested?
- transesophageal echocardiogram
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll patients of both sexes, aged> 18 years, with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow
Who may be able to join
- age> 18 years
- written informed consent
- cardiac surgery with cardiopulmonary bypass (CPB)
- New York Heart Association (NYHA) class I, II, III
- preoperative serum creatinine less than 1.2 mg / dl
Who cannot join
- contraindications to Trans Esophageal Ultrasound (TEE) based on American Society of Anesthesiologists (ASA) recommendations (esophageal or gastric diseases or previous surgery)
- history of non-coronary arterial pathologies
- atrial fibrillation
- preoperative serum creatinine greater than 1.2 mg / dl • NYHA class IV
- emergency cardiac surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A,Gemelli IRCCS
Roma, 00168
Gabriella Arlotta, MD, +390630154848, gabriella.arlotta@policlinicogemelli.it
Temistocle Taccheri, +390630154848, temistocle.taccheri@policlinicogemelli.it
About this study
The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. In fact, a reduction in Nitric Oxide (NO) production by the endothelium, an increase in systemic vascular resistance and an increased risk of cerebral and renal hypoperfusion have been observed and can result in potential organ damage. Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity. Its incidence varies according to different definitions, but can reach 30%. In some series, 1-5% of patients require renal replacement therapy in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine are associated with worsening prognosis and the risk of chronic kidney disease. The pathophysiology of AKI in cardiac surgery is complex and still partly unknown.Recently a technique has been described that allows to measure the blood velocity in the right renal artery and in the superior mesenteric artery using the transesophageal echocardiogram (TEE); this technique allows to view these arteries and measure the speed of the blood with good precision because the insonation angle (ie the angle formed by the ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this methodology allows you to monitor blood velocity in the right renal artery and superior mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which the blood velocity values in the renal arteries during cardiac surgery were used to calculate the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. At present, therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little studied during cardiopulmonary by-pass (CPB) and has never been evaluated during CPB with continuous flow; in particular, the possible variation in blood velocity measured during CPB compared to the baseline values measured before extracorporeal circulation and its correlation with the onset of postoperative renal failure is not known.
Read the detailed description
The cardiopulmonary by-pass (CPB) technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. In fact, a reduction in NO production by the endothelium, an increase in systemic vascular resistance and an increased risk of cerebral and renal hypoperfusion have been observed and can result in potential organ damage.
Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity. Its incidence varies according to different definitions, but can reach 30%. In some series, 1-5% of patients require renal replacement therapy (RRT) in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine (sCr) are associated with worsening prognosis and the risk of chronic kidney disease (CKD). The pathophysiology of AKI in cardiac surgery is complex and still partly unknown. It is believed that one of the main causative factors is hypoperfusion and renal hypoxia, in particular of the medullary region; this would result in a vasoconstriction of the afferent arterioles to the glomerulus and a reduction in filtration. Risk factors associated with the increased incidence of AKI include bleeding, use of the aortic pump, excessive cardiopulmonary bypass duration, excessive haemodilution, insufficient pump flow, or insufficient blood pressure. Hypothermia, which also has a protective effect against hypoperfusion and tissue hypoxia, could induce AKI by increasing renal vascular resistance and favoring medullary hypoxia during subsequent rewarming.
In addition to AKI, another complication of cardiac surgery, rarer but associated with a higher mortality, is acute mesenteric ischemia; the most frequent type is non-occlusive mesenteric ischemia (NOMI) which seems to have as a predisposing cause a reduction or maldistribution of splanchnic blood flow and the use of vasoconstrictors.
Recently a technique has been described that allows to measure the blood velocity in the right renal artery and in the superior mesenteric artery using the transesophageal echocardiogram (TEE); this technique allows to view these arteries and measure the speed of the blood with good precision because the insonation angle (ie the angle formed by the ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this methodology allows you to monitor blood velocity in the right renal artery and superior mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which the blood velocity values in the renal arteries during cardiac surgery were used to calculate the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. The calculation of these indices, however, requires the use of a pulsatile blood flow to generate a periodic variation of the blood velocity, and they are not evaluable during CPB since the current practice in almost all centers is to use a continuous blood flow. At present, therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little studied during CPB and has never been evaluated during CPB with continuous flow; in particular, the possible variation in blood velocity measured during CPB compared to the baseline values measured before extracorporeal circulation and its correlation with the onset of postoperative renal failure is not known.
- Conditions
- Heart Surgical Procedure
- Being tested
- transesophageal echocardiogram
- Keywords
- cardiopulmonary by-pass, transesophageal echocardiogram, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transesophageal echocardiogramDiagnostic test
To measure mean blood velocity at the level of the right renal and superior mesenteric artery
| Study group | Role | What they receive |
|---|---|---|
| Heart Surgical Patients | Patients with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow Receives: Diagnostic Test: transesophageal echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Right renal artery mean blood velocity (cm/sec) before CPB
Measured: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Right renal artery mean blood velocity (cm/sec) before CPB
Measured: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Right renal artery mean blood velocity (cm/sec) during CPB
Measured: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Right renal artery mean blood velocity (cm/sec) during CPB
Measured: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Right renal artery mean blood velocity (cm/sec) during CPB
Measured: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Secondary outcomes (59)
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Superior mesenteric artery mean blood velocity (cm/sec) before CPB
Measured: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Superior mesenteric artery mean blood velocity (cm/sec) before CPB
Measured: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Superior mesenteric artery mean blood velocity (cm/sec) during CPB
Measured: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Superior mesenteric artery mean blood velocity (cm/sec) during CPB
Measured: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Superior mesenteric artery mean blood velocity (cm/sec) during CPB
Measured: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between mean blood velocity values and hemodynamic parameters: cardiopulmonary by-pass (CPB) blood flow
Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between mean blood velocity values and CPB blood flow
Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and CPB blood flow
Correlation between right renal artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and cardiopulmonary by-pass (CPB) blood flow
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia, during cardiopulmonary by-pass
Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)
Correlation between right renal artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and MAP
Correlation between right renal artery mean blood velocity (cm/sec) and MAP (mmHg)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and MAP
Correlation between right arterial mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and MAP
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and MAP
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)
Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)
Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and arterial PCO2
Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and arterial PCO2
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and Temperature
Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and Temperature
Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and Temperature
Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and Temperature
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and Temperature
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and Temperature
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees9
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Correlation between right renal artery mean blood velocity (cm/sec) and negative pressure applied to the venous drainage (vacuum-assist venous drainage) (mmHg)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)
Measured: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Correlation between superior mesenteric artery mean blood velocity values and VAVD (mmHg)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)
Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Measured: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)
Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Measured: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)
Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Measured: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Measured: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Measured: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Measured: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)
Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according Kidney Disease Improving Global Outcomes (KDIGO) definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
Measured: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)
Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
Measured: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)
Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
Measured: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Evaluation of serum Cystatin C in low right renal artery mean blood velocity during CPB
Comparison between serum Cystatin C mean level (mg/L) measured in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) measured during CPB
Measured: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocity
Comparison between urinary uNGAL mean level (ng/ml) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB
Measured: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocity
Comparison between urinary uNGAL mean level (ng/ml) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB
Measured: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity values
Comparison between mean arterial lactate (mmol/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) during CPB
Measured: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity
Comparison between arterial lactate (mmol/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery mean blood velocity (cm/sec) measured during CPB
Measured: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Evaluation of amylase in low superior mesenteric artery mean blood velocity
Comparison between mean serum amylase (UI/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB
Measured: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
Evaluation of amylase in low superior mesenteric artery mean blood velocity
Comparison between mean serum amylase (UI/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB
Measured: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Feasibility of measurement of right renal artery blood velocity during CPB
the number of patients in whom is possible to measure right renal artery blood velocity during CPB
Measured: During CPB
Feasibility of measurement of superior mesenteric artery blood velocity during CPB
the number of patients in whom is possible to measure superior mesenteric artery blood velocity during CPB
Measured: During CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 Feb 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.ssa Gabriella Arlotta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Cavaliere Franco, M.D., Study chair, Fondazione Policlinico Agostino Gemelli IRRCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009809
- Sponsor's protocol ID
- 4708
- Status last verified
- Nov 2025
- First submitted
- 26 May 2022
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Velocity Variation in Right Renal and Superior Mesenteric Arteries During Cardio-pulmonary Bypass
- ClinicalTrials.gov ID
- NCT06009809
- Acronym / sponsor ID
- 4708
- Conditions
- Heart Surgical Procedure
- Keywords
- cardiopulmonary by-pass, transesophageal echocardiogram, acute kidney injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. In fact, a reduction in Nitric Oxide (NO) production by the endothelium, an increase in systemic vascular resistance and an increased risk of cerebral and renal hypoperfusion have been observed and can result in potential organ damage. Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity. Its incidence varies according to different definitions, but can reach 30%. In some series, 1-5% of patients require renal replacement therapy in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine are associated with worsening prognosis and the risk of chronic kidney disease. The pathophysiology of AKI in cardiac surgery is complex and still partly unknown.Recently a technique has been described that allows to measure the blood velocity in the right renal artery and in the superior mesenteric artery using the transesophageal echocardiogram (TEE); this technique allows to view these arteries and measure the speed of the blood with good precision because the insonation angle (ie the angle formed by the ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this methodology allows you to monitor blood velocity in the right renal artery and superior mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which the blood velocity values in the renal arteries during cardiac surgery were used to calculate the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. At present, therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little studied during cardiopulmonary by-pass (CPB) and has never been evaluated during CPB with continuous flow; in particular, the possible variation in blood velocity measured during CPB compared to the baseline values measured before extracorporeal circulation and its correlation with the onset of postoperative renal failure is not known.
Detailed description
The cardiopulmonary by-pass (CPB) technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. In fact, a reduction in NO production by the endothelium, an increase in systemic vascular resistance and an increased risk of cerebral and renal hypoperfusion have been observed and can result in potential organ damage.
Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity. Its incidence varies according to different definitions, but can reach 30%. In some series, 1-5% of patients require renal replacement therapy (RRT) in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine (sCr) are associated with worsening prognosis and the risk of chronic kidney disease (CKD). The pathophysiology of AKI in cardiac surgery is complex and still partly unknown. It is believed that one of the main causative factors is hypoperfusion and renal hypoxia, in particular of the medullary region; this would result in a vasoconstriction of the afferent arterioles to the glomerulus and a reduction in filtration. Risk factors associated with the increased incidence of AKI include bleeding, use of the aortic pump, excessive cardiopulmonary bypass duration, excessive haemodilution, insufficient pump flow, or insufficient blood pressure. Hypothermia, which also has a protective effect against hypoperfusion and tissue hypoxia, could induce AKI by increasing renal vascular resistance and favoring medullary hypoxia during subsequent rewarming.
In addition to AKI, another complication of cardiac surgery, rarer but associated with a higher mortality, is acute mesenteric ischemia; the most frequent type is non-occlusive mesenteric ischemia (NOMI) which seems to have as a predisposing cause a reduction or maldistribution of splanchnic blood flow and the use of vasoconstrictors.
Recently a technique has been described that allows to measure the blood velocity in the right renal artery and in the superior mesenteric artery using the transesophageal echocardiogram (TEE); this technique allows to view these arteries and measure the speed of the blood with good precision because the insonation angle (ie the angle formed by the ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this methodology allows you to monitor blood velocity in the right renal artery and superior mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which the blood velocity values in the renal arteries during cardiac surgery were used to calculate the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. The calculation of these indices, however, requires the use of a pulsatile blood flow to generate a periodic variation of the blood velocity, and they are not evaluable during CPB since the current practice in almost all centers is to use a continuous blood flow. At present, therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little studied during CPB and has never been evaluated during CPB with continuous flow; in particular, the possible variation in blood velocity measured during CPB compared to the baseline values measured before extracorporeal circulation and its correlation with the onset of postoperative renal failure is not known.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Surgical Patients | – | Diagnostic Test: transesophageal echocardiogramPatients with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients of both sexes, aged> 18 years, with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow
Key inclusion criteria (5 listed)
- age> 18 years
- written informed consent
- cardiac surgery with cardiopulmonary bypass (CPB)
- New York Heart Association (NYHA) class I, II, III
- preoperative serum creatinine less than 1.2 mg / dl
Key exclusion criteria (5 listed)
- contraindications to Trans Esophageal Ultrasound (TEE) based on American Society of Anesthesiologists (ASA) recommendations (esophageal or gastric diseases or previous surgery)
- history of non-coronary arterial pathologies
- atrial fibrillation
- preoperative serum creatinine greater than 1.2 mg / dl • NYHA class IV
- emergency cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transesophageal echocardiogramTo measure mean blood velocity at the level of the right renal and superior mesenteric artery | Diagnostic test | Heart Surgical Patients |
Primary outcome
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
Right renal artery mean blood velocity (cm/sec) before CPB
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
Right renal artery mean blood velocity (cm/sec) before CPB
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Right renal artery mean blood velocity (cm/sec) during CPB
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Right renal artery mean blood velocity (cm/sec) during CPB
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Right renal artery mean blood velocity (cm/sec) during CPB
59 secondary outcomes
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between mean blood velocity values and hemodynamic parameters: cardiopulmonary by-pass (CPB) blood flow
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between mean blood velocity values and CPB blood flow
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and CPB blood flow
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and cardiopulmonary by-pass (CPB) blood flow
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia, during cardiopulmonary by-pass
Correlation between superior mesenteric artery mean blood velocity values and CPB blood flow
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and MAP
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and MAP
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and MAP
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and MAP
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and arterial PCO2
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and arterial PCO2
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean mean blood velocity values and laboratory parameters (Hematocrit)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean mean blood velocity values and Hematocrit
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and Temperature
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and Temperature
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and Temperature
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and Temperature
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and Temperature
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and Temperature
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cavaliere Franco, M.D. study chair
Fondazione Policlinico Agostino Gemelli IRRCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Surgical Procedure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Arlotta, M.D. (+390630154848, g.arlotta72@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB) (time frame: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.