Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05817539

Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure

Led by Hospices Civils de Lyon · Updated on 2026-01-08

250

Participants Needed

14

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In Intensive Care Unit (ICU) patients with acute kidney injury (AKI) and treated with renal replacement therapy (RRT) often present a fluid overload which is associated with morbidity (mechanical ventilation duration increase, kidney recovery decrease) and mortality. Patients' prognostic could be improved by correcting the fluid overload with net ultrafiltration (UFnet) however it may lead to harmful iatrogenic hypovolemia responsible of deleterious ischemic lesions. In usual practice, UF net prescription are variable and there are different international recommendations. Some observational studies suggest that using a UFnet between 1 et 1.75 mL/kg/h in fluid overloaded patient decrease mortality. Fluid overload increases morbidity and mortality, particularly in RRT. Studies without RRT argue for an efficacy of management by decreasing the fluid overload .Cohort studies suggest to use a moderate UFnet instead of a low UFnet. Some data from studies on early versus late RRT that relate the fluid balance or correct the fluid overload during the early strategy argue for a beneficial effect of an early deresuscitation strategy Consequently, the impact of a moderate UFnet (to decrease the fluid overload) compared to a low UFnet (to stabilize the fluid overload) in a randomized interventional study could be assessed. The study hypothesis is that : an early fluid overload deresuscitation protocol with a high UFnet (2 ml/kg/h) targeting both the negativation of cumulated fluid balance to reach a dry weight and the maintenance of tissue perfusion. Compared to fluid overload deresuscitation protocol with a low UFnet (between 0 and 1 ml/kg/h) to reach a stabilization of cumulated fluid balance without monitoring the tissue perfusion. could improve overall, renal, hemodynamic and respiratory prognosis in fluid overloaded patients with renal replacement therapy in ICU

CONDITIONS

Official Title

Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Acute kidney injury treated with continuous renal replacement therapy in ICU for less than 7 days
  • At least one additional organ failure during ICU stay (mechanical ventilation, oxygen therapy, fluid resuscitation over 1000 ml, or vasopressor use over 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 per kilogram per minute
  • No hypoperfusion signs defined by at least two of the following: capillary refill time over 3 seconds at the finger, marbling score over 2, lactate over 2 mmol/L, or central venous oxygen saturation below 60%
  • Fluid overload defined as more than 5% increase from baseline weight or obvious edema over 1 cm depth in lumbar or flank areas
Not Eligible

You will not qualify if you...

  • Chronic renal failure requiring hemodialysis before ICU admission
  • Mechanical circulatory support such as ECMO or LVAD
  • Pregnant, breastfeeding, or women of childbearing age
  • Stroke with central neurological symptoms and compatible brain imaging within the past 30 days
  • Intestinal ischemia within the past 7 days without surgery
  • Current participation in another interventional study or within exclusion period
  • Under guardianship, curatorship, or legal protection
  • Lack of signed informed consent by patient or relative
  • Not affiliated with a social security or similar scheme

AI-Screening

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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

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Research Team

M

Matthias JACQUET LAGREZE, MD PhD

CONTACT

J

Julia CANTERINI, project manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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