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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05640518
Other study ID # 38RC22.0274
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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