A NEW WAY TO DETECT ACUTE KIDNEY INJURY

NCT07198906 | Not Yet Recruiting

• 2 other identifiers: 2023/213/OB2023-A02389-36
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Acute renal failure after cardiac surgery is a common postoperative complication, affecting approximately 20% of patients. It is associated with an increase in short-term mortality and an increase in hospital stay; but is also associated with an increase in long-term mortality of up to 30% at 5 years, even if renal function recovers upon discharge. Its origin is multifactorial: intraoperative hypoperfusion, including hemodynamic variations related to extracorporeal circulation or bleeding, postoperative hypoperfusion related to cardiogenic or vasoplegic shock, ischemia-reperfusion phenomena leading to cell lysis or inflammation at the tubular level, inflammation and oxidative stress related to extracorporeal circulation, and hemolysis are the main causes. Hydro-sodium overload and associated venous congestion is also one of the etiologies of acute renal failure in post-operative cardiac surgery and is associated with increased mortality. The proposed pathophysiological mechanism is based on the decrease in renal tissue perfusion pressure due to the increase in venous pressure. In the extreme, the increase in pressure in the renal capsule could lead to true renal ischemia due to engorgement. This renal congestion can be diagnosed based on clinical signs, biological signs (such as NT-pro-BNP) or by monitoring by central venous pressure (CVP). However, these statistical tools have low diagnostic performance, and new tools based on ultrasound and Doppler are being developed. Indeed, alterations in venous flow in the renal, suprahepatic and portal veins, reflecting the increase in pressures there, are associated with the onset of acute renal failure in post-operative cardiac surgery.

Conditions

Acute Renal Failure

Keywords

heart surgery; postoperative complication

Outcome Measures

Primary Outcomes (1)

• To study the association between the VEXUS score and the occurrence of acute renal failure post-operatively after cardiac surgery.

  Onset of acute renal failure characterized by a score greater than or equal to KDIGO 1. (KDIGO 1 : Creatinine increased by \>26.5 µmol/L or 1.5-1.9 times the reference value, Diuresis \<0.5 mL/kg/h for 6-12 hours; KDIGO 2 : Creatinine x 2-2.9 compared to the reference value, Diuresis \< 0.5/mL/kg/h for \> 12h; KDIGO 3 : Creatinine x 3 or increase of \>353.6 µmol/L compared to the reference value Use of extra-renal replacement therapy, Diuresis \< 0.3 mL/kg/h for \> 24 hours or anuria for \> 12 hours.)

  visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2

Secondary Outcomes (11)

• Study of the correlation or association between the VEXUS score and - the value of Central Venous Pressure (CVP)

  visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2

• Study of the correlation or association between the VEXUS score and the NT-pro-BNP level

  visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2

• Study of the correlation or association between the VEXUS score and the Hydro-sodium balance in intensive care

  visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2

• Study of the correlation or association between the VEXUS score and The time of the first dose of diuretics administered

  visit Hour no. 02, i.e. 2 hours after the intervention; visit Day 1 and visit Day 2

• Study of the correlation or association between the VEXUS score and The onset of chronic renal failure (assessed at 3 months)

  visit month 3

Interventions

Determination of VEXUS score and onset of chronic renal failure OTHER

The aim is to prospectively evaluate the association between the ultrasound score (VEXUS) and the occurrence of acute renal failure post-operatively following cardiac surgery. The VEXUS (Venous Excess UltraSound) score is an ultrasound tool used in medicine to assess systemic venous congestion, i.e. excess pressure in the venous system linked to volume overload or right heart failure. The VEXUS score relies on ultrasound of the inferior vena cava (IVC) to assess the extent of congestion in this vein. score 0 : Normal IVC + Normal Dopplers; score 1 : Dilated IVC + altered hepatic venous Doppler, but normal portal vein; score 2 : Portal vein shows significant pulsatility; score 3 : Severe pulsatility + marked alteration of hepatic and portal flow

Eligibility Criteria

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

Study Population

Adult patient undergoing valve surgery and/or bypass surgery under extracorporeal circulation (ECC).

You may qualify if:

• Adult patient undergoing valve surgery and/or bypass surgery under cardiopulmonary bypass (CPB).
• Patient who has read and understood the information letter and does not object to participating in the study.
• Member of or beneficiary of a social security scheme.

You may not qualify if:

• Age under 18 years
• Severe chronic kidney disease with glomerular filtration rate (GFR) \< 30 mL/min/1.73 m² and/or requiring dialysis treatment
• Kidney, heart, and liver transplant recipients
• Coronary artery bypass grafting without CPB
• Conditions that may interfere with portal and liver Doppler imaging (cirrhosis, suspected cirrhosis, portal thrombosis)
• Mechanical left ventricular support
• Circulatory support such as ECLS
• Pregnant women
• Patient refusal
• Protected incapacitated persons (judicial protection, guardianship, curatorship, deprivation of liberty)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

As part of routine intensive care, blood samples are taken daily to measure creatinine, blood ionogram, NT-pro-BNP, and troponin levels. The results of these measurements will be analyzed as part of the study

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chanez CA AIT ALI, Doctor

CONTACT

02 32 88 27 07; Chanez.Ait-Ali@chu-rouen.fr

Clément CB BOSSE, Doctor

CONTACT

02 32 88 27 07; clement.bosse@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)