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

NCT05640518 | Unknown

• 1 other identifier: 38RC22.0274
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; Acute Renal Failure; Renal Insufficiency; Acute Renal Insufficiency

Keywords

Renal failure; Cardiac surgery; VExUS score; venous congestion

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  3 days

• Diagnostic performances of the VExUS Score for postoperative acute renal failure

  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

  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

  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

  3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Scheduled cardiac surgery
• Affiliated to a social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 18311732 BACKGROUND

• 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.

  PMID: 30371304 BACKGROUND

• 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.

  PMID: 32270297 BACKGROUND

• 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.

  PMID: 21940396 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Acute Kidney Injury; Hyperemia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timothée ABAZIOU, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothée ABAZIOU, MD

CONTACT

04 76 76 68 79; tabaziou@chu-grenoble.fr

Mehdi KARAOUI

CONTACT

04 76 76 68 79; MKaraoui@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 7, 2022
• Study Start: December 19, 2022
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 25, 2023

Record last verified: 2022-10

Locations

FR (1)