IntraoperativeNCT07232277
Venous Congestion and Cardiac Surgery-Associated Acute Kidney Injury
An observational study of Intraoperative and Venous Congestion, run by Zhuan Zhang at 1 site in China.
Trial summary
Venous pressure is often overlooked as an important hemodynamic parameter. Elevated venous pressure and blood stasis in organ tissues can lead to interstitial edema. Intraoperative venous blood stasis can rapidly increase interstitial pressures within organ tissues, especially in organs encapsulated by tissue… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative, Venous Congestion, Cardiac Surgery-associated Acute Kidney Injury
- What is being tested?
- collection of demographic characteristics and comorbidities, surgery-related parameters and kidney function assessments and collection of biological (laboratory) parameters
- Type of treatment
- Injection or infusion
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 30 Sep 2026
- 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: Patients scheduled to undergo elective cardiac surgery
Who may be able to join
- Patients scheduled to undergo elective cardiac surgery;
- ≥ 18 years.
Who cannot join
- Contraindications for TEE;
- Emergency cardiac surgery;
- Major vascular surgery;
- Redo cardiac surgery;
- Abnormal preoperative renal function;
- Severe chronic kidney disease (estimated glomerular filtration rate < 15 ml/min/1.73 m2 or dialysis);
Show all 17Show fewer
- History of kidney transplantation;
- Severe infection requiring continuous antibiotic therapy；
- Severe preoperative heart failure with left ventricular ejection fraction < 30%;
- A critical preoperative state (mechanical circulatory support, extracorporeal membrane oxygenation, current renal replacement therapy [RRT], mechanical ventilation, or cardiac arrest necessitating resuscitation);
- Multi-organ dysfunction;
- Known conditions that may interfere with the assessment or interpretation of hepatic vein, portal vein blood flow (such as liver cirrhosis or portal vein thrombosis) or the renal vein blood flow and renal artery blood flow (such as urinary tract obstruction);
- Planned cardiac transplantation or ventricular assist device implantation;
- Pregnancy;
- Insufficient ultrasonographic imaging;
- Restarting CPB after first CPB cessation during surgery;
- Requirement for cardiac assist devices (ECMO, IABP, or ventricular assist device) after CPB intraoperatively.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 368 Hanjiang Middle Road
Yangzhou, Jiangsu, 225012
Zhuan Zhang, MD, +8615062791355 ext. +8615062791355, zhangzhuancg@163.com
About this study
Official title: Intraoperative Venous Congestion and Cardiac Surgery-associated Acute Kidney Injury (CSA-AKI): a Prospective Cohort Study
Venous pressure is often overlooked as an important hemodynamic parameter. Elevated venous pressure and blood stasis in organ tissues can lead to interstitial edema. Intraoperative venous blood stasis can rapidly increase interstitial pressures within organ tissues, especially in organs encapsulated by tissue envelopes, such as the kidney, thereby rapidly reducing effective circulating blood flow to the organ. Systemic venous blood stasis, which tends to occur in patients with right heart failure or pulmonary hypertension, as well as in patients with fluid overload, can lead to intraoperative stasis in multiple organs and tissues, mediating the development of multisystem complications, including acute kidney injury. Therefore, timely, effective, and accurate intraoperative assessment of systemic venous blood stasis is particularly important.
When right heart failure and/or volume overload occurs in the body, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns.
The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion during cardiac surgery is associated with postoperative CSA-AKI. In doing so, we seek to identify a promising physiological marker that can provide cues for the prediction of CSA-AKI. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and explore the relationship between each separate venous congestion and AKI after cardiac surgery.
- Being tested
- collection of demographic characteristics and comorbidities, surgery-related parameters and kidney function assessments, collection of biological (laboratory) parameters, collection of hemodynamic parameters, collection of echocardiographic parameters and venous ultrasound assessments
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of demographic characteristics and comorbiditiesOther
- gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification.
- smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, contrast agent, aspirin, and spironolactone use.
surgery-related parameters and kidney function assessmentsOther
- surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications.
- baseline and postoperative eGFR, duration of mechanical ventilation, duration of vasopressor support, postoperative CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, postoperative delirium, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up.
- a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason.
- CSA-AKI diagnosed using the KDIGO criteria.
- acute kidney disease assessment.
- major adverse kidney events.
collection of biological (laboratory) parametersOther
- WBC, CRP, IL-6, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD.
- creatinine, uric acid, BUN, CysC, β2-MG, eGFR.
- CK-MB, high-sensitivity troponin, NT pro-BNP, BNP.
- hemoglobin, hematocrit, sodium, arterial lactate, liver enzymes.
collection of hemodynamic parametersOther
- blood pressure, heart rate, CVP;
- CO, CI, SV, SVI,SVV;
- intra-abdominal pressure;
- vasoactive drug doses in the first hour in the ICU.
collection of echocardiographic parameters and venous ultrasound assessmentsOther
- Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices.
- Right ventricular systolic function, including TAPSE. Right ventricular diastolic function, inferred from an hepatic vein flow in the absence of a dysrhythmia or pacing.
- Inferior vena cava (IVC) measurements.
- Hepatic vein Doppler parameters.
- Portal vein Doppler parameters.
- Renal vein Doppler parameters.
- Renal artery blood flow Doppler parameters.
| Study group | Role | What they receive |
|---|---|---|
| Participant | Adult patients scheduled to undergo elective cardiac surgery Receives: Other: collection of demographic characteristics and comorbidities; Other: surgery-related parameters and kidney function assessments; Other: collection of biological (laboratory) parameters; Other: collection of hemodynamic parameters; Other: collection of echocardiographic parameters and venous ultrasound assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria)
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntraoperativeStudies of the same condition, open and under way.
- 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
- Investigators
- Zhuan Zhang, MD, Principal investigator, The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232277
- Sponsor's protocol ID
- 20240916
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Venous Congestion and Cardiac Surgery-associated Acute Kidney Injury (CSA-AKI): a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07232277
- Acronym / sponsor ID
- 20240916
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Nov 2025 (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.
Venous pressure is often overlooked as an important hemodynamic parameter. Elevated venous pressure and blood stasis in organ tissues can lead to interstitial edema. Intraoperative venous blood stasis can rapidly increase interstitial pressures within organ tissues, especially in organs encapsulated by tissue envelopes, such as the kidney, thereby rapidly reducing effective circulating blood flow to the organ. Systemic venous blood stasis, which tends to occur in patients with right heart failure or pulmonary hypertension, as well as in patients with fluid overload, can lead to intraoperative stasis in multiple organs and tissues, mediating the development of multisystem complications, including acute kidney injury. Therefore, timely, effective, and accurate intraoperative assessment of systemic venous blood stasis is particularly important.
When right heart failure and/or volume overload occurs in the body, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns.
The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion during cardiac surgery is associated with postoperative CSA-AKI. In doing so, we seek to identify a promising physiological marker that can provide cues for the prediction of CSA-AKI. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and explore the relationship between each separate venous congestion and AKI after cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Other: collection of demographic characteristics and comorbidities, Other: surgery-related parameters and kidney function assessments, Other: collection of biological (laboratory) parameters, Other: collection of hemodynamic parameters, Other: collection of echocardiographic parameters and venous ultrasound assessmentsAdult patients scheduled to undergo elective cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo elective cardiac surgery
Key inclusion criteria (2 listed)
- Patients scheduled to undergo elective cardiac surgery;
- ≥ 18 years.
Key exclusion criteria (17 listed)
- Contraindications for TEE;
- Emergency cardiac surgery;
- Major vascular surgery;
- Redo cardiac surgery;
- Abnormal preoperative renal function;
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 |
|---|---|---|
| collection of demographic characteristics and comorbidities1. gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification. 2. smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, contrast agent, aspirin, and spironolactone use. | Other | Participant |
| surgery-related parameters and kidney function assessments1. surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications. 2. baseline and postoperative eGFR, duration of mechanical ventilation, duration of vasopressor support, postoperative CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, postoperative delirium, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up. 3. a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason. 4. CSA-AKI diagnosed using the KDIGO criteria. 5. acute kidney disease assessment. 6. major adverse kidney events. | Other | Participant |
| collection of biological (laboratory) parameters1. WBC, CRP, IL-6, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD. 2. creatinine, uric acid, BUN, CysC, β2-MG, eGFR. 3. CK-MB, high-sensitivity troponin, NT pro-BNP, BNP. 4. hemoglobin, hematocrit, sodium, arterial lactate, liver enzymes. | Other | Participant |
| collection of hemodynamic parameters1. blood pressure, heart rate, CVP; 2. CO, CI, SV, SVI,SVV; 3. intra-abdominal pressure; 4. vasoactive drug doses in the first hour in the ICU. | Other | Participant |
| collection of echocardiographic parameters and venous ultrasound assessments1. Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices. 2. Right ventricular systolic function, including TAPSE. Right ventricular diastolic function, inferred from an hepatic vein flow in the absence of a dysrhythmia or pacing. 3. Inferior vena cava (IVC) measurements. 4. Hepatic vein Doppler parameters. 5. Portal vein Doppler parameters. 6. Renal vein Doppler parameters. 7. Renal artery blood flow Doppler parameters. | Other | Participant |
Primary outcome
Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria)
Time frame: 7 days after surgery
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 18 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Intraoperative
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
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.
Zhuan Zhang, MD principal investigator
The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University
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 Intraoperative and Venous Congestion, run by Zhuan Zhang at 1 site in China.
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 2 inclusion and 17 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 18 Nov 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 China. 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 Zhuan Zhang, MD (+8615062791355, zhangzhuancg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria) (time frame: 7 days after surgery). 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 18 Nov 2025.