Acute Kidney InjuryNCT06440161
Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery
An observational study of Acute Kidney Injury, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD). Methods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP).
- How many people
- 543 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Eligible patients underwent surgery for TAAD.
Who may be able to join
- 1) Eligible patients were adults, aged 18 or older.
Who cannot join
- Lacking preoperative serum creatinine (Scr) values
- Insufficient hemodynamic or laboratory data
- Exhibiting a preoperative Scr level ≥133 μmol/L
- Patients with renal insufficiency before surgery
- Patients on preoperative dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Intraoperative Haemodynamic Instability With Postoperative Mortality, Renal Injury, and Stroke in Type A Aortic Dissection Surgery: A Retrospective Cohort Analysis
Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD).
Methods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). The primary outcomes were acute kidney injury (AKI) and acute injury disease (AKD). The secondary outcomes encompassed death and stroke. Restricted cubic spline regression model was used to adjust for confounding factors and multiple comparisons.
Read the detailed description
Type A aortic dissection (TAAD) is a catastrophic cardiac macrovascular disease with a striking in-hospital mortality rate of 22%-31%. Among the myriad of complications following TAAD surgeries, acute kidney injury (AKI) is one of the most prevalent, boasting an incidence of 40-55%. Notably, this incidence surpasses that observed in other cardiovascular procedures, such as coronary artery bypass grafting (CABG), which ranges from 10-20%, and aortic valve replacement (AVR) at 17-23%. Furthermore, the occurrence of AKI post-TAAD surgeries has been linked with escalated in-hospital, short-term, and long-term mortalities, as well as significant complications.
Preoperatively, patients with TAAD usually have poorly controlled blood pressure, long-term hypertension can cause chronic kidney damage. In some cases, involving renal artery origins, renal perfusion insufficiency may exist preoperatively. Intraoperatively, the kidneys need to undergo a complete ischemic phase of deep hypothermic circulatory arrest (DHCA), inflammatory reactions associated with cardiopulmonary bypass (CPB), and a large number of blood and fluid transfusions could potentially cause renal dysfunction. Patients are at high risk for postoperative surgical site infection following TAAD procedure, further exacerbating acute kidney injury. The myriad factors mentioned above collectively exacerbate the elevated occurrence of kidney injury following Type A Aortic Dissection (TAAD) surgeries when juxtaposed with other cardiac surgical procedures. Pathological anatomy and surgical procedure intricacies pose formidable challenges in mitigation. Consequently, the pursuit of precise intraoperative hemodynamic management objectives aimed at maximizing organ perfusion has emerged as a focal point in contemporary research endeavours. A study encompassing 5,127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKI/AKD risk determinants. However, the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKI/AKD remains elusive. There's a paucity of comprehensive evaluations, primarily due to a dearth of long-term data from expansive TAAD cohorts. The investigators' primary objective was to discern the correlation between intraoperative hypotension and venous congestion durations and magnitudes at varied thresholds during TAAD surgeries and the subsequent risks of postoperative AKI/AKD. As a secondary objective, the investigators sought to elucidate the association between intraoperative hemodynamic and major adverse events, including stroke and mortality. The investigators hypothesize that both intraoperative hypotension and venous congestion are paramount predictors for postoperative AKI and AKD following TAAD surgeries.
- Conditions
- Acute Kidney Injury
- Being tested
- Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP).
- Keywords
- Acute Kidney Injury, Intraoperative Hypotension, Venous Congestion, Acute Kidney Disease, Type A Aortic Dissection
- Medical subject headings
- Acute Kidney Injury, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP).Other
After the induction of anaesthesia, a central venous or pulmonary artery catheter was positioned. Based on prior studies, thresholds for central venous pressure were set at 10, 12, 16, and 20 mm Hg. Venous congestion was quantified by time exceeding each CVP threshold and the area under the curve (AUC) surpassing each CVP threshold in mmHg × min. Assessments were limited to pre- and post-CPB periods, as the venous drainage cannulate generated negative CVP during CPB.
An arterial catheter was installed upon room admission. Continuous arterial blood pressure monitoring commenced after exposure to atmospheric pressure and calibration to zero. The MAP was determined using the formula: 2/3 × diastolic blood pressure + 1/3 × systolic blood pressure. Data were logged by automated software every minute. Established thresholds for MAP were 55, 65, and 75 mm Hg. Hypotension was quantified as (1) time under each MAP threshold in minutes and (2) the AUC below each MAP threshold in mmHg × min.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of AKI
AKI diagnosis adhered to the Kidney Disease Improvement Global Prognosis Organization (KDIGO) criteria.
Measured: After the surgery，up to 7 days
The Incidence of AKD
AKD staging was determined based on the Acute Disease Quality Initiative (ADQI) Working Group consensus, using available Scr values from 8 to 90 days post-surgery.
Measured: After the surgery，longer than 7 days but within 90 days
Secondary outcomes (5)
The days of stay in hospital
The days of stay in hospital
Measured: perioperatively
The days of stay in ICU
The days of stay in ICU
Measured: after surgery
The incidence of in-hospital mortality
The incidence of in-hospital mortality
Measured: after surgery
The incidence of 30-day all-cause mortality
The incidence of 30-day all-cause mortality
Measured: after surgery
The incidence of stroke
Stroke diagnosis adhered to National Institute of Neurological Disorders and Stroke rt PA Stroke study Group
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Retrospective
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-li Ge, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440161
- Sponsor's protocol ID
- KY20230918-KS-02
- Status last verified
- Sep 2023
- First submitted
- 6 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intraoperative Haemodynamic Instability With Postoperative Mortality, Renal Injury, and Stroke in Type A Aortic Dissection Surgery: A Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT06440161
- Acronym / sponsor ID
- KY20230918-KS-02
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Intraoperative Hypotension, Venous Congestion, Acute Kidney Disease, Type A Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 3 Jun 2024 (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.
Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD).
Methods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). The primary outcomes were acute kidney injury (AKI) and acute injury disease (AKD). The secondary outcomes encompassed death and stroke. Restricted cubic spline regression model was used to adjust for confounding factors and multiple comparisons.
Detailed description
Type A aortic dissection (TAAD) is a catastrophic cardiac macrovascular disease with a striking in-hospital mortality rate of 22%-31%. Among the myriad of complications following TAAD surgeries, acute kidney injury (AKI) is one of the most prevalent, boasting an incidence of 40-55%. Notably, this incidence surpasses that observed in other cardiovascular procedures, such as coronary artery bypass grafting (CABG), which ranges from 10-20%, and aortic valve replacement (AVR) at 17-23%. Furthermore, the occurrence of AKI post-TAAD surgeries has been linked with escalated in-hospital, short-term, and long-term mortalities, as well as significant complications.
Preoperatively, patients with TAAD usually have poorly controlled blood pressure, long-term hypertension can cause chronic kidney damage. In some cases, involving renal artery origins, renal perfusion insufficiency may exist preoperatively. Intraoperatively, the kidneys need to undergo a complete ischemic phase of deep hypothermic circulatory arrest (DHCA), inflammatory reactions associated with cardiopulmonary bypass (CPB), and a large number of blood and fluid transfusions could potentially cause renal dysfunction. Patients are at high risk for postoperative surgical site infection following TAAD procedure, further exacerbating acute kidney injury. The myriad factors mentioned above collectively exacerbate the elevated occurrence of kidney injury following Type A Aortic Dissection (TAAD) surgeries when juxtaposed with other cardiac surgical procedures. Pathological anatomy and surgical procedure intricacies pose formidable challenges in mitigation. Consequently, the pursuit of precise intraoperative hemodynamic management objectives aimed at maximizing organ perfusion has emerged as a focal point in contemporary research endeavours. A study encompassing 5,127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKI/AKD risk determinants. However, the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKI/AKD remains elusive. There's a paucity of comprehensive evaluations, primarily due to a dearth of long-term data from expansive TAAD cohorts. The investigators' primary objective was to discern the correlation between intraoperative hypotension and venous congestion durations and magnitudes at varied thresholds during TAAD surgeries and the subsequent risks of postoperative AKI/AKD. As a secondary objective, the investigators sought to elucidate the association between intraoperative hemodynamic and major adverse events, including stroke and mortality. The investigators hypothesize that both intraoperative hypotension and venous congestion are paramount predictors for postoperative AKI and AKD following TAAD surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients underwent surgery for TAAD.
Key inclusion criteria (1 listed)
- 1) Eligible patients were adults, aged 18 or older.
Key exclusion criteria (5 listed)
- Lacking preoperative serum creatinine (Scr) values
- Insufficient hemodynamic or laboratory data
- Exhibiting a preoperative Scr level ≥133 μmol/L
- Patients with renal insufficiency before surgery
- Patients on preoperative dialysis
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 |
|---|---|---|
| Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP).After the induction of anaesthesia, a central venous or pulmonary artery catheter was positioned. Based on prior studies, thresholds for central venous pressure were set at 10, 12, 16, and 20 mm Hg. Venous congestion was quantified by time exceeding each CVP threshold and the area under the curve (AUC) surpassing each CVP threshold in mmHg × min. Assessments were limited to pre- and post-CPB periods, as the venous drainage cannulate generated negative CVP during CPB. An arterial catheter was installed upon room admission. Continuous arterial blood pressure monitoring commenced after exposure to atmospheric pressure and calibration to zero. The MAP was determined using the formula: 2/3 × diastolic blood pressure + 1/3 × systolic blood pressure. Data were logged by automated software every minute. Established thresholds for MAP were 55, 65, and 75 mm Hg. Hypotension was quantified as (1) time under each MAP threshold in minutes and (2) the AUC below each MAP threshold in mmHg × min. | Other | – |
Primary outcome
The Incidence of AKI
Time frame: After the surgery，up to 7 days
AKI diagnosis adhered to the Kidney Disease Improvement Global Prognosis Organization (KDIGO) criteria.
The Incidence of AKD
Time frame: After the surgery，longer than 7 days but within 90 days
AKD staging was determined based on the Acute Disease Quality Initiative (ADQI) Working Group consensus, using available Scr values from 8 to 90 days post-surgery.
5 secondary outcomes
The days of stay in hospital
Time frame: perioperatively
The days of stay in ICU
Time frame: after surgery
The incidence of in-hospital mortality
Time frame: after surgery
The incidence of 30-day all-cause mortality
Time frame: after surgery
The incidence of stroke
Time frame: after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ya-li Ge study director
The First Affiliated Hospital with Nanjing Medical 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 Acute Kidney Injury, run by Nanjing First Hospital, Nanjing Medical University 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 1 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: finished, as of the sponsor's last update on 3 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incidence of AKI (time frame: After the surgery，up to 7 days). The study lists 2 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 3 Jun 2024.