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

Renal Failure Clinical Trial

— ValiVexus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640518
• Other study ID #: 38RC22.0274
• Status: Recruiting
• Start date: December 19, 2022
• Est. completion date: November 2024

Study information

• Verified date: October 2022
• Source: University Hospital, Grenoble
• Contact: Timothée ABAZIOU, MD
• Phone: 04 76 76 68 79
• Email: tabaziou[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 119
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Acute Renal Insufficiency
• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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	3 days
Secondary	Diagnostic performances of the VExUS Score for postoperative acute renal failure	Sensitivity, NPV, PPV	3 days
Secondary	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.	3 days
Secondary	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	3 days
Secondary	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	3 days
Secondary	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	3 days
Secondary	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.	3 days
Secondary	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)	From randomization until date of postoperative need of extra renal replacement therapy, assessed up to a variable period of time estimated to 2 weeks.
Secondary	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.	From randomization until date of discharge, assessed up to a variable period of time estimated to 2 weeks.
Secondary	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.	1 month after admission in intensive care
Secondary	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.	3 days
Secondary	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.	3 days