Actively Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure in Intensive Care Unit A Randomized Study
Led by Hospices Civils de Lyon · Updated on 2026-01-08
250
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating early fluid removal strategies in Intensive Care Unit (ICU) patients with acute kidney injury (AKI) who are receiving renal replacement therapy (RRT) and have fluid overload. Fluid overload in these patients is linked to increased complications and higher risk of death. The study compares two fluid removal approaches to see if a moderate removal rate guided by tissue blood flow monitoring can improve kidney, heart, and lung outcomes compared to a low removal rate that stabilizes fluid without such monitoring. Participants are randomly assigned to one of two groups. The experimental group will have fluid removed at a rate of 2 ml per kilogram per hour, adjusted based on tolerance and blood flow, aiming to reach their original body weight. If this target is not met within 24 hours, the rate can be increased. The control group will have fluid removal set between 0 and 1 ml/kg/h to maintain body weight stability, with adjustments as needed. Fluid removal may be paused temporarily if signs of poor blood flow or intolerance occur. During the study, participants will be closely monitored with assessments of organ function, kidney recovery, heart rhythm, and respiratory support needs for up to 30 days. The main measure is the number of days without needing organ support by day 30. Other evaluations include mortality, time off mechanical ventilation and vasopressors, ICU stay length, and complications such as strokes or intestinal ischemia. The trial aims to determine if a guided moderate fluid removal improves overall health outcomes in this critical patient group.
CONDITIONS
Brief Title
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Acute kidney injury treated by continuous renal replacement therapy in ICU for less than 7 days
- At least one additional organ failure during ICU stay (mechanical ventilation, oxygen therapy, vascular filling > 1000 ml, or vasopressor use > 12 hours)
- Weight loss less than 3% since starting net ultrafiltration or cumulative net ultrafiltration less than 2000 ml before inclusion
- Norepinephrine dose less than 0.5 micrograms/kg/min
- Absence of hypoperfusion signs defined by at least two of the following: capillary refill time > 3 seconds at the finger, marbling score > 2, lactate > 2 mmol/L, or ScvO2 < 60%
- Fluid overload defined as fluid overload > 5% of baseline weight or obvious edema of lumbar region or flanks (edema > 1 cm bucket depth)
You will not qualify if you...
- Chronic renal failure on hemodialysis before ICU admission
- Mechanical circulatory support such as ECMO or LVAD
- Pregnant, breastfeeding, or women of child-bearing age
- Stroke with neurological symptoms and compatible brain imaging within the last 30 days
- Documented non-operated intestinal ischemia within the last 7 days
- Participation in another interventional study or ongoing exclusion period that may interfere
- Under guardianship, curatorship, or safeguard of justice
- Absence of signed informed consent by patient or relative
- Not affiliated to a social security scheme or similar beneficiaries
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 - Up to 7 days or until clinical decision to stop renal replacement therapy
Participants undergo renal replacement therapy with specific fluid removal strategies to manage body weight and tissue perfusion in the intensive care unit.
Daily visits during renal replacement therapy
Duration - Up to 30 days after treatment
Participants are monitored for clinical outcomes including organ function, mortality, and renal recovery up to 30 days after treatment.
Visits at days 5 and 30 for assessment
Trial Site Locations
Total: 14 locations
1
Centre Hospitalier d'Ajaccio
Ajaccio, France, 20090
Not Yet Recruiting
2
CHU Amiens-Picardie
Amiens, France, 80480
Not Yet Recruiting
3
Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, France, 69500
Actively Recruiting
4
CHU Caen Normandie
Caen, France, 14033
Not Yet Recruiting
5
Service de Réanimation, CHU de Dijon
Dijon, France, 21000
Actively Recruiting
6
GHP Saint Joseph Marie Lannelongue
Le Plessis-Robinson, France, 92350
Not Yet Recruiting
7
CHU Lille - Hôpital Roger Salengro
Lille, France, 59037
Not Yet Recruiting
8
Hôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, France, 69003
Actively Recruiting
9
Hôpital de la Croix Rousse
Lyon, France, 69004
Not Yet Recruiting
10
Hôpital de la Croix Rousse
Lyon, France, 69004
Actively Recruiting
11
Service de Réanimation, Clinique de la Sauvegarde
Lyon, France, 69009
Actively Recruiting
12
Hôpital Edouard Herriot
Lyon, France, 69437
Not Yet Recruiting
13
Département d'anesthésie réanimation Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
14
Hôpitaux de Bradois - CHRU Nancy
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
Research Team
M
Matthias JACQUET LAGREZE, MD PhD
J
Julia CANTERINI, project manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
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