Acute Renal FailureVEX-CARDSNCT07198906
A New Way to Detect Acute Kidney Injury
An observational study of Acute Renal Failure, run by University Hospital, Rouen at 1 site in France.
Trial summary
Acute renal failure after cardiac surgery is a common postoperative complication, affecting approximately 20% of patients. It is associated with an increase in short-term mortality and an increase in hospital stay; but is also associated with an increase in long-term mortality of up to 30% at 5 years, even if renal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- Determination of VEXUS score and onset of chronic renal failure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 1 Apr 2029
- How long will I take part?
- 1 Year
- 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: Adult patient undergoing valve surgery and/or bypass surgery under extracorporeal circulation (ECC).
Who may be able to join
- Adult patient undergoing valve surgery and/or bypass surgery under cardiopulmonary bypass (CPB).
- Patient who has read and understood the information letter and does not object to participating in the study.
- Member of or beneficiary of a social security scheme.
Who cannot join
- Age under 18 years
- Severe chronic kidney disease with glomerular filtration rate (GFR) < 30 mL/min/1.73 m² and/or requiring dialysis treatment
- Kidney, heart, and liver transplant recipients
- Acute kidney failure at the time of inclusion, defined by KDIGO criteria
- Coronary artery bypass grafting without CPB
- Conditions that may interfere with portal and liver Doppler imaging (cirrhosis, suspected cirrhosis, portal thrombosis)
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- Mechanical left ventricular support
- Circulatory support such as ECLS
- Pregnant women
- Patient refusal
- Protected incapacitated persons (judicial protection, guardianship, curatorship, deprivation of liberty)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Way to Detect Acute Kidney Injury After Cardiac Surgery
Acute renal failure after cardiac surgery is a common postoperative complication, affecting approximately 20% of patients. It is associated with an increase in short-term mortality and an increase in hospital stay; but is also associated with an increase in long-term mortality of up to 30% at 5 years, even if renal function recovers upon discharge.
Its origin is multifactorial: intraoperative hypoperfusion, including hemodynamic variations related to extracorporeal circulation or bleeding, postoperative hypoperfusion related to cardiogenic or vasoplegic shock, ischemia-reperfusion phenomena leading to cell lysis or inflammation at the tubular level, inflammation and oxidative stress related to extracorporeal circulation, and hemolysis are the main causes.
Hydro-sodium overload and associated venous congestion is also one of the etiologies of acute renal failure in post-operative cardiac surgery and is associated with increased mortality. The proposed pathophysiological mechanism is based on the decrease in renal tissue perfusion pressure due to the increase in venous pressure. In the extreme, the increase in pressure in the renal capsule could lead to true renal ischemia due to engorgement. This renal congestion can be diagnosed based on clinical signs, biological signs (such as NT-pro-BNP) or by monitoring by central venous pressure (CVP). However, these statistical tools have low diagnostic performance, and new tools based on ultrasound and Doppler are being developed. Indeed, alterations in venous flow in the renal, suprahepatic and portal veins, reflecting the increase in pressures there, are associated with the onset of acute renal failure in post-operative cardiac surgery.
Read the detailed description
More recently, a retrospective postoperative cardiac surgery study assessed venous congestion using the VEXUS (Venous Excess UltraSound) composite score. This score explores the diameter of the inferior vena cava (IVC) and venous flows in the hepatic, portal, and renal veins, and is associated with acute renal failure. Its diagnostic performance is based on the joint analysis of all Doppler flows and offers better diagnostic performance than isolated CVP measurement.
The primary objective of this study is to prospectively investigate this ultrasound score and its association with the development of acute renal failure postoperatively after cardiac surgery. Due to the morbidity and mortality associated with renal failure described above, a secondary objective of the study is to investigate the association between the VEXUS score and the development of chronic renal failure.
- Conditions
- Acute Renal Failure
- Being tested
- Determination of VEXUS score and onset of chronic renal failure
- Keywords
- heart surgery, postoperative complication
- Medical subject headings
- Acute Kidney Injury, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of VEXUS score and onset of chronic renal failureOther
The aim is to prospectively evaluate the association between the ultrasound score (VEXUS) and the occurrence of acute renal failure post-operatively following cardiac surgery. The VEXUS (Venous Excess UltraSound) score is an ultrasound tool used in medicine to assess systemic venous congestion, i.e. excess pressure in the venous system linked to volume overload or right heart failure. The VEXUS score relies on ultrasound of the inferior vena cava (IVC) to assess the extent of congestion in this vein. score 0 : Normal IVC + Normal Dopplers; score 1 : Dilated IVC + altered hepatic venous Doppler, but normal portal vein; score 2 : Portal vein shows significant pulsatility; score 3 : Severe pulsatility + marked alteration of hepatic and portal flow
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the association between the VEXUS score and the occurrence of acute renal failure post-operatively after cardiac surgery.
Onset of acute renal failure characterized by a score greater than or equal to KDIGO 1. (KDIGO 1 : Creatinine increased by >26.5 µmol/L or 1.5-1.9 times the reference value, Diuresis <0.5 mL/kg/h for 6-12 hours; KDIGO 2 : Creatinine x 2-2.9 compared to the reference value, Diuresis < 0.5/mL/kg/h for > 12h; KDIGO 3 : Creatinine x 3 or increase of >353.6 µmol/L compared to the reference value Use of extra-renal replacement therapy, Diuresis < 0.3 mL/kg/h for > 24 hours or anuria for > 12 hours.)
Measured: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Secondary outcomes (11)
Study of the correlation or association between the VEXUS score and - the value of Central Venous Pressure (CVP)
Studying the correlation between the VEXUS score and PVC allows us to validate or not the VEXUS as a reliable non-invasive tool for assessing venous congestion.
Measured: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and the NT-pro-BNP level
Studying the relationship between VEXUS score and NT-proBNP (biomarker of cardiac volume overload) helps determine whether venous ultrasound can be a reliable substitute for the biomarker to detect volume congestion, especially in critically ill patients.
Measured: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and the Hydro-sodium balance in intensive care
to determine whether the VEXUS score, which reflects venous congestion assessed by ultrasound, is correlated or associated with the hydro-sodium balance, i.e. the quantity of liquid and sodium retained or eliminated by a patient in intensive care
Measured: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and The time of the first dose of diuretics administered
Determine whether a high VEXUS score is associated with early administration of diuretics, which would allow us to Validate VEXUS as a therapeutic decision-making tool
Measured: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and The onset of chronic renal failure (assessed at 3 months)
To determine whether the VEXUS score, used from hospitalization, can predict chronic renal evolution at 3 months.
Measured: visit month 3
Study of the correlation or association between the VEXUS score and The length of hospitalization
To determine whether the VEXUS score, measured at the beginning or during hospitalization, is correlated or associated with the total length of hospital stay (unity : day)
Measured: Visit 12 months
Study of the correlation or association between the VEXUS score and The onset of chronic renal failure (assessed at 12 months)
To determine whether the VEXUS score, used from hospitalization, can predict chronic renal evolution at 12 months.
Measured: visit month 12
Study of the correlation or association between the VEXUS score and The mortality (assessed at 3 months)
Validating VEXUS as a prognostic marker with mortality at 3 months.
Measured: visit month 3
Study of the correlation or association between the VEXUS score and The mortality (assessed at 12 months)
Validating VEXUS as a prognostic marker with mortality at 12 months.
Measured: visit month 12
Study of the correlation or association between the VEXUS score and The quality of life (assessed at 3 months)
Validate VEXUS as a prognostic marker of 3-month mortality with EQ-5D-5L quiz. The EQ-5D-5L is a standardized questionnaire designed to measure health-related quality of life (HRQoL). Five levels are assessed: Mobility; Self-care; Usual activities; Pain/discomfort and Five levels are assessed: Anxiety/depression. Each dimension has 5 severity levels, rated from 1 to 5. (level 1 : No problem; level 2 : Mild problem; level 3 : Moderate problem; level 4 : Severe problem; level 5 : Extreme disability / very severe problem). The patient's overall health status is determined on a scale of 0 to 100 (0 = worst imaginable health status; 100 = best imaginable health status)
Measured: visit month 3
Study of the correlation or association between the VEXUS score and The quality of life (assessed at 12 months)
Validate VEXUS as a prognostic marker of 12-month mortality with EQ-5D-5L quiz. The EQ-5D-5L is a standardized questionnaire designed to measure health-related quality of life (HRQoL). Five levels are assessed: Mobility; Self-care; Usual activities; Pain/discomfort and Five levels are assessed: Anxiety/depression. Each dimension has 5 severity levels, rated from 1 to 5. (level 1 : No problem; level 2 : Mild problem; level 3 : Moderate problem; level 4 : Severe problem; level 5 : Extreme disability / very severe problem). The patient's overall health status is determined on a scale of 0 to 100 (0 = worst imaginable health status; 100 = best imaginable health status)
Measured: visit month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Why it stopped: no Inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198906
- Sponsor's protocol ID
- 2023/213/OB
- Other IDs
- 2023-A02389-36
- Acronym
- VEX-CARDS
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Way to Detect Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07198906
- Acronym / sponsor ID
- VEX-CARDS / 2023/213/OB
- Conditions
- Acute Renal Failure
- Keywords
- heart surgery, postoperative complication
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no Inclusion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 30 Sep 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.
Acute renal failure after cardiac surgery is a common postoperative complication, affecting approximately 20% of patients. It is associated with an increase in short-term mortality and an increase in hospital stay; but is also associated with an increase in long-term mortality of up to 30% at 5 years, even if renal function recovers upon discharge.
Its origin is multifactorial: intraoperative hypoperfusion, including hemodynamic variations related to extracorporeal circulation or bleeding, postoperative hypoperfusion related to cardiogenic or vasoplegic shock, ischemia-reperfusion phenomena leading to cell lysis or inflammation at the tubular level, inflammation and oxidative stress related to extracorporeal circulation, and hemolysis are the main causes.
Hydro-sodium overload and associated venous congestion is also one of the etiologies of acute renal failure in post-operative cardiac surgery and is associated with increased mortality. The proposed pathophysiological mechanism is based on the decrease in renal tissue perfusion pressure due to the increase in venous pressure. In the extreme, the increase in pressure in the renal capsule could lead to true renal ischemia due to engorgement. This renal congestion can be diagnosed based on clinical signs, biological signs (such as NT-pro-BNP) or by monitoring by central venous pressure (CVP). However, these statistical tools have low diagnostic performance, and new tools based on ultrasound and Doppler are being developed. Indeed, alterations in venous flow in the renal, suprahepatic and portal veins, reflecting the increase in pressures there, are associated with the onset of acute renal failure in post-operative cardiac surgery.
Detailed description
More recently, a retrospective postoperative cardiac surgery study assessed venous congestion using the VEXUS (Venous Excess UltraSound) composite score. This score explores the diameter of the inferior vena cava (IVC) and venous flows in the hepatic, portal, and renal veins, and is associated with acute renal failure. Its diagnostic performance is based on the joint analysis of all Doppler flows and offers better diagnostic performance than isolated CVP measurement.
The primary objective of this study is to prospectively investigate this ultrasound score and its association with the development of acute renal failure postoperatively after cardiac surgery. Due to the morbidity and mortality associated with renal failure described above, a secondary objective of the study is to investigate the association between the VEXUS score and the development of chronic renal failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient undergoing valve surgery and/or bypass surgery under extracorporeal circulation (ECC).
Key inclusion criteria (3 listed)
- Adult patient undergoing valve surgery and/or bypass surgery under cardiopulmonary bypass (CPB).
- Patient who has read and understood the information letter and does not object to participating in the study.
- Member of or beneficiary of a social security scheme.
Key exclusion criteria (11 listed)
- Age under 18 years
- Severe chronic kidney disease with glomerular filtration rate (GFR) < 30 mL/min/1.73 m² and/or requiring dialysis treatment
- Kidney, heart, and liver transplant recipients
- Acute kidney failure at the time of inclusion, defined by KDIGO criteria
- Coronary artery bypass grafting without CPB
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 |
|---|---|---|
| Determination of VEXUS score and onset of chronic renal failureThe aim is to prospectively evaluate the association between the ultrasound score (VEXUS) and the occurrence of acute renal failure post-operatively following cardiac surgery. The VEXUS (Venous Excess UltraSound) score is an ultrasound tool used in medicine to assess systemic venous congestion, i.e. excess pressure in the venous system linked to volume overload or right heart failure. The VEXUS score relies on ultrasound of the inferior vena cava (IVC) to assess the extent of congestion in this vein. score 0 : Normal IVC + Normal Dopplers; score 1 : Dilated IVC + altered hepatic venous Doppler, but normal portal vein; score 2 : Portal vein shows significant pulsatility; score 3 : Severe pulsatility + marked alteration of hepatic and portal flow | Other | – |
Primary outcome
To study the association between the VEXUS score and the occurrence of acute renal failure post-operatively after cardiac surgery.
Time frame: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Onset of acute renal failure characterized by a score greater than or equal to KDIGO 1. (KDIGO 1 : Creatinine increased by >26.5 µmol/L or 1.5-1.9 times the reference value, Diuresis <0.5 mL/kg/h for 6-12 hours; KDIGO 2 : Creatinine x 2-2.9 compared to the reference value, Diuresis < 0.5/mL/kg/h for > 12h; KDIGO 3 : Creatinine x 3 or increase of >353.6 µmol/L compared to the reference value Use of extra-renal replacement therapy, Diuresis < 0.3 mL/kg/h for > 24 hours or anuria for > 12 hours.)
11 secondary outcomes
Study of the correlation or association between the VEXUS score and - the value of Central Venous Pressure (CVP)
Time frame: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and the NT-pro-BNP level
Time frame: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and the Hydro-sodium balance in intensive care
Time frame: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and The time of the first dose of diuretics administered
Time frame: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2
Study of the correlation or association between the VEXUS score and The onset of chronic renal failure (assessed at 3 months)
Time frame: visit month 3
Study of the correlation or association between the VEXUS score and The length of hospitalization
Time frame: Visit 12 months
Study of the correlation or association between the VEXUS score and The onset of chronic renal failure (assessed at 12 months)
Time frame: visit month 12
Study of the correlation or association between the VEXUS score and The mortality (assessed at 3 months)
Time frame: visit month 3
Study of the correlation or association between the VEXUS score and The mortality (assessed at 12 months)
Time frame: visit month 12
Study of the correlation or association between the VEXUS score and The quality of life (assessed at 3 months)
Time frame: visit month 3
Study of the correlation or association between the VEXUS score and The quality of life (assessed at 12 months)
Time frame: visit month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Failure, run by University Hospital, Rouen at 1 site in France.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 2 Jun 2026. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
To study the association between the VEXUS score and the occurrence of acute renal failure post-operatively after cardiac surgery. (time frame: visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2). 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 2 Jun 2026.