Actively Recruiting
Feasibility of a Randomised Trial Comparing a Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery: a Pilot Randomised Trial.
Led by Hospices Civils de Lyon · Updated on 2025-04-13
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating fluid management strategies in patients who develop acute kidney injury after cardiac surgery involving extracorporeal circulation. This condition, affecting over 30% of such patients, can range from transient to persistent kidney problems and may lead to chronic kidney disease with increased long-term health risks. Venous congestion, reflecting fluid overload, has been identified as an important factor in worsening kidney injury, and an ultrasound-based scoring system called the VeXUS score has been developed to better predict this condition than traditional measurements. The study compares two fluid management approaches during the first 3 days after surgery. One group receives fluid removal guided by the VeXUS score, with diuretics given to achieve a target urine output if the score is greater than 1. This involves a specific protocol for administering furosemide and thiazide diuretics, along with monitoring and managing electrolyte imbalances to prevent complications. The other group receives usual care, where fluid management is decided by the attending physician without access to the VeXUS score. Participants are monitored closely during the 48 hours after inclusion to assess study feasibility and fluid management effects. Assessments include daily ultrasound to estimate the VeXUS score, checks for venous congestion, hemodynamic stability, metabolic disturbances, and kidney function recovery. Researchers will evaluate adherence to the intervention protocol, kidney injury persistence, need for renal replacement therapy, and kidney-related adverse events up to 30 days. The study aims to determine if guided fluid removal can support kidney recovery after surgery while ensuring patient safety.
CONDITIONS
Brief Title
Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation
- Acute kidney injury defined by KDIGO criteria
- Vasoactive inotropic score less than 45 and capillary refill time less than 3 seconds
- Informed written consent
You will not qualify if you...
- Hypokalaemia less than 3.5 mmol/L
- Hyponatremia less than 125 mmol/L
- Hypernatremia greater than 145 mmol/L
- Metabolic alkalosis with pH greater than 7.50
- Impossibility to measure capillary refill time
- Chronic liver disease
- Cirrhosis with portal hypertension
- Known thrombus of the inferior vena cava
- Mechanical circulatory assistance such as ECMO or mono left ventricular assistance
- Severe pre-operative chronic kidney disease with GFR less than 30 mL/min/1.73m2
- Need for renal replacement therapy anticipated within 24 hours
- Known hypersensitivity to Furosemide and/or hydrochlorothiazide
- Severe allergy to wheat
- Participation in another interventional study with ongoing exclusion period
- Pregnant, breast-feeding or women of childbearing age without suitable contraception
- Patients under guardianship, curatorship or safeguard of justice
- Patients under psychiatric care
- Patients not affiliated to a social security scheme or similar
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 to 48 hours
Participants receive fluid management guided by VeXUS score or usual care after cardiac surgery. The VeXUS score is estimated daily by ultrasound for 3 postoperative days, with diuretic-induced fluid removal administered if indicated.
Daily visits for up to 3 days
Duration - Up to 30 days
Participants are monitored for renal outcomes and adverse events up to 30 days after inclusion.
Visits at Day 1, Day 2, 48 hours, and Day 30
Trial Site Locations
Total: 2 locations
1
Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon
Bron, Bron, France, 69500
Not Yet Recruiting
2
Hopital cardiologique Louis Pradel
Bron, France
Actively Recruiting
Research Team
J
Jean-Luc Fellahi, MD
R
RUSTE Martin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here