Clinical trial NCT05640518: External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery
Official title: External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure
Acute Renal Failure
Renal Insufficiency
Acute Renal Insufficiency
Keywords: Renal failure
Cardiac surgery
VExUS score
venous congestion
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: 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.
measure: Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure.
timeFrame: 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:
measure: Correlation between the VExUS score and a postoperative acute renal failure
timeFrame: 3 days
measure: Diagnostic performances of the VExUS Score for postoperative acute renal failure
timeFrame: 3 days
measure: 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
timeFrame: 3 days
measure: 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
timeFrame: 3 days
measure: 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
timeFrame: 3 days
measure: 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
timeFrame: 3 days
measure: 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.
timeFrame: 3 days
measure: Correlation between VExUS score and the use of extra renal replacement therapy
timeFrame: From randomization until date of postoperative need of extra renal replacement therapy, assessed up to a variable period of time estimated to 2 weeks.
measure: Correlation between VExUS score and length of stay
timeFrame: From randomization until date of discharge, assessed up to a variable period of time estimated to 2 weeks.
measure: Correlation between VExUS score and 1-month mortality
timeFrame: 1 month after admission in intensive care
measure: Correlation between renal arterial resistance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)
timeFrame: 3 days
measure: Correlation between renal venous impedance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)
timeFrame: 3 days
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Timothée ABAZIOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Beaubien-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.
citation: Beaubien-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.
citation: Bossard 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.