Renal FailureValiVexusNCT05640518
External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery
An observational study of Renal Failure and Acute Renal Failure, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery. The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Acute Renal Failure, Renal Insufficiency
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2022to Nov 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: Adult patients scheduled for cardiac surgery will be screened. They will be referred to the preoperative anesthesia consultation by the cardiac surgeons, which is a legal requirement in France. The geographical area of origin corresponds to the recruitment area of the cardiac surgery department of the Grenoble-Alpes University Hospital.
Who may be able to join
- Scheduled cardiac surgery
- Affiliated to a social security system
Who cannot join
- Emergency surgery
- Chronic renal failure defined by a glomerular filtration rate of less than 30ml/min or dialysis.
- renal transplant recipients
- Cirrhosis and portal hypertension
- Setting up a left ventricular assist device implantation
- Patient under ECMO (ExtraCorporeal Membrane Oxygenation), intra-aortic balloon pump, or a mechanical circulatory support device such as IMPELLA
Show all 12Show fewer
- No available operator to perform ultrasound scans
- Patients objecting to the use of their data in research
- Subject under guardianship or subject deprived of freedom
- Pregnant or breastfeeding women
- Resume surgery within 48 hours of scheduled surgery
- Lack of a trained operator to perform D+1 and D+2 ultrasound
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble
Timothée ABAZIOU, MD
Mehdi KARAOUI
About this study
Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.
The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.
This score is predictive of the onset of acute renal failure in the first 3 days after surgery.
The VExUS score has not been validated in an external and prospective way in cardiac surgery.
Read the detailed description
Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.
The pathophysiology in this context is complex, poorly understood and the causes are multiple: underlying nephropathy, intra- or postoperative haemodynamic instability, the use of an extracorporeal circulation, inflammation, etc.
One of the other possible etiologies is venous congestion. This may be due to volume overload and/or isolated global or right heart dysfunction.
Early treatment could prevent the onset of ARF or reduce its consequences, hence the importance of being able to predict its onset.
The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.
This score is predictive of the onset of acute renal failure in the first 3 days after surgery.
The VExUS score has not been validated in an external and prospective way in cardiac surgery.
- Keywords
- Renal failure, Cardiac surgery, VExUS score, venous congestion
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury, Hyperemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure (defined by a creatininemia increase by 26.5 µmol/L in 48 hours).
correlation between operator in term of VExUS staging (VExUS score will be assessed at day 1, 2 and 3 after the surgery, in intensive care unit.
Measured: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks.
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure.
Specificity of the VExUS score to predict an acute kidney failure will be evaluated
Measured: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks
Secondary outcomes (12)
Correlation between the VExUS score and a postoperative acute renal failure
Use of a multivariable COX regression to evaluate the correlation between the VExUS score measured at day 1, 2 and 3 and a post-operative acute renal failure during the stay in intensive care unit
Measured: 3 days
Diagnostic performances of the VExUS Score for postoperative acute renal failure
Sensitivity, NPV, PPV
Measured: 3 days
Correlation between central venous pressure (CVP) and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Central venous pressure (CVP). The values will be taken during the ultrasound scans at Day 0, Day 1 and Day 2. The units of pressure are mmHg. A value greater than 12mmHg will be considered high, a lower value as not high. The CVP is measured by a central venous line.
Measured: 3 days
Correlation between daily fluid balance and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Water balance: 24-hour input-output balance, in millilitres, collected daily. Values measured at Day 0, Day 1, Day 2
Measured: 3 days
Correlation between daily fluid balance and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Water balance: including the weight in Kg compared to the reference weight established during the anaesthetic consultation. Values measured at Day 0, Day 1, Day 2
Measured: 3 days
Correlation between an isolated component of the VExUS score, echocardiography and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
An isolated component of the VExUS score that is measured at D0; D1; D2 by ultrasound
- Inferior vena cava diameter
- Doppler profile of the suprahepatic vein
- Doppler profile of portal vein
- Renal vein Doppler profile
Measured: 3 days
Correlation between an echocardiographic abnormality and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value.
Ultrasound assessment of the left and right heart: Visual LVEF, sub-aortic LTI, Mitral Doppler (E wave, A wave, E/A ratio, deceleration time), LV/VD ratio (less than or greater than 0.6); TAPSE (unit: mm); S wave (unit: cm/seconds); LTI flow (unit: m/seconds); diameter (unit: mm) and ICV compliance. Values also taken at D0, D1 and D2.
Measured: 3 days
Correlation between VExUS score and the use of extra renal replacement therapy
Use of extra renal replacement therapy: based on dialysis prescriptions, binary value (yes/no) regardless of the method used (CVVHF, CVVHDF, CVVHD)
Measured: From randomization until date of postoperative need of extra renal replacement therapy, assessed up to a variable period of time estimated to 2 weeks.
Correlation between VExUS score and length of stay
Length of stay in days: in intensive care, cardiac surgery and rehabilitation. Determined thanks to medical records.
Measured: From randomization until date of discharge, assessed up to a variable period of time estimated to 2 weeks.
Correlation between VExUS score and 1-month mortality
Mortality: binary (yes/no) at 1 month. The data will be collected by phone call to the patient or a relative, or by consulting the medical record.
Measured: 1 month after admission in intensive care
Correlation between renal arterial resistance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)
Renal arterial resistance index are measured at D0; D1; D2 during the ultrasound scans.
Measured: 3 days
Correlation between renal venous impedance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)
Veinous impedance index are measured at D0; D1; D2 during the ultrasound scans.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start19 Dec 2022
- Primary completionMay 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothée ABAZIOU, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640518
- Sponsor's protocol ID
- 38RC22.0274
- Acronym
- ValiVexus
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hoste EA, Cruz DN, Davenport A, Mehta RL, Piccinni P, Tetta C, Viscovo G, Ronco C. The epidemiology of cardiac surgery-associated acute kidney injury. Int J Artif Organs. 2008 Feb;31(2):158-65. doi: 10.1177/039139880803100209.
PubMed 18311732Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961.
PubMed 30371304Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.
PubMed 32270297Bossard G, Bourgoin P, Corbeau JJ, Huntzinger J, Beydon L. Early detection of postoperative acute kidney injury by Doppler renal resistive index in cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2011 Dec;107(6):891-8. doi: 10.1093/bja/aer289. Epub 2011 Sep 22.
PubMed 21940396
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05640518
- Acronym / sponsor ID
- ValiVexus / 38RC22.0274
- Keywords
- Renal failure, Cardiac surgery, VExUS score, venous congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 7 Dec 2022 (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 is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.
The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.
This score is predictive of the onset of acute renal failure in the first 3 days after surgery.
The VExUS score has not been validated in an external and prospective way in cardiac surgery.
Detailed description
Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.
The pathophysiology in this context is complex, poorly understood and the causes are multiple: underlying nephropathy, intra- or postoperative haemodynamic instability, the use of an extracorporeal circulation, inflammation, etc.
One of the other possible etiologies is venous congestion. This may be due to volume overload and/or isolated global or right heart dysfunction.
Early treatment could prevent the onset of ARF or reduce its consequences, hence the importance of being able to predict its onset.
The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.
This score is predictive of the onset of acute renal failure in the first 3 days after surgery.
The VExUS score has not been validated in an external and prospective way in cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for cardiac surgery will be screened. They will be referred to the preoperative anesthesia consultation by the cardiac surgeons, which is a legal requirement in France. The geographical area of origin corresponds to the recruitment area of the cardiac surgery department of the Grenoble-Alpes University Hospital.
Key inclusion criteria (2 listed)
- Scheduled cardiac surgery
- Affiliated to a social security system
Key exclusion criteria (12 listed)
- Emergency surgery
- Chronic renal failure defined by a glomerular filtration rate of less than 30ml/min or dialysis.
- renal transplant recipients
- Cirrhosis and portal hypertension
- Setting up a left ventricular assist device implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure (defined by a creatininemia increase by 26.5 µmol/L in 48 hours).
Time frame: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks.
correlation between operator in term of VExUS staging (VExUS score will be assessed at day 1, 2 and 3 after the surgery, in intensive care unit.
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure.
Time frame: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks
Specificity of the VExUS score to predict an acute kidney failure will be evaluated
12 secondary outcomes
Correlation between the VExUS score and a postoperative acute renal failure
Time frame: 3 days
Diagnostic performances of the VExUS Score for postoperative acute renal failure
Time frame: 3 days
Correlation between central venous pressure (CVP) and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Time frame: 3 days
Correlation between daily fluid balance and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Time frame: 3 days
Correlation between daily fluid balance and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Time frame: 3 days
Correlation between an isolated component of the VExUS score, echocardiography and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value
Time frame: 3 days
Correlation between an echocardiographic abnormality and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value.
Time frame: 3 days
Correlation between VExUS score and the use of extra renal replacement therapy
Time frame: From randomization until date of postoperative need of extra renal replacement therapy, assessed up to a variable period of time estimated to 2 weeks.
Correlation between VExUS score and length of stay
Time frame: From randomization until date of discharge, assessed up to a variable period of time estimated to 2 weeks.
Correlation between VExUS score and 1-month mortality
Time frame: 1 month after admission in intensive care
Correlation between renal arterial resistance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)
Time frame: 3 days
Correlation between renal venous impedance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 18311732Hoste EA, Cruz DN, Davenport A, Mehta RL, Piccinni P, Tetta C, Viscovo G, Ronco C. The epidemiology of cardiac surgery-associated acute kidney injury. Int J Artif Organs. 2008 Feb;31(2):158-65. doi: 10.1177/039139880803100209.
- Background: PubMed 30371304Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961.
- Background: PubMed 32270297Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.
- Background: PubMed 21940396Bossard G, Bourgoin P, Corbeau JJ, Huntzinger J, Beydon L. Early detection of postoperative acute kidney injury by Doppler renal resistive index in cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2011 Dec;107(6):891-8. doi: 10.1093/bja/aer289. Epub 2011 Sep 22.
- Individual participant dataSharing planned: Undecided
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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.
Timothée ABAZIOU, MD principal investigator
University Hospital, Grenoble
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 Renal Failure and Acute Renal Failure, run by University Hospital, Grenoble 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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothée ABAZIOU, MD (04 76 76 68 79, tabaziou@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure (defined by a creatininemia increase by 26.5 µmol/L in 48 hours). (time frame: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks.). 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?
On the ClinicalTrials.gov record for NCT05640518, which also lists 4 linked publications.
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 25 Jan 2023.