External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery (ValiVexus)

January 20, 2023 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France
        • Recruiting
        • University Hospital Grenoble
        • Contact:
          • Timothée ABAZIOU, MD
        • Contact:
          • Mehdi KARAOUI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Scheduled cardiac surgery
  • Affiliated to a social security system

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 (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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the VExUS score and a postoperative acute renal failure
Time Frame: 3 days
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
3 days
Diagnostic performances of the VExUS Score for postoperative acute renal failure
Time Frame: 3 days
Sensitivity, NPV, PPV
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
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.
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
Water balance: 24-hour input-output balance, in millilitres, collected daily. Values measured at Day 0, Day 1, Day 2
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
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
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

An isolated component of the VExUS score that is measured at D0; D1; D2 by ultrasound

  1. Inferior vena cava diameter
  2. Doppler profile of the suprahepatic vein
  3. Doppler profile of portal vein
  4. Renal vein Doppler profile
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
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.
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.
Use of extra renal replacement therapy: based on dialysis prescriptions, binary value (yes/no) regardless of the method used (CVVHF, CVVHDF, CVVHD)
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.
Length of stay in days: in intensive care, cardiac surgery and rehabilitation. Determined thanks to medical records.
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
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.
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
Renal arterial resistance index are measured at D0; D1; D2 during the ultrasound scans.
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
Veinous impedance index are measured at D0; D1; D2 during the ultrasound scans.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Timothée ABAZIOU, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC22.0274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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