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RECRUITING
NCT05817539
NA

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

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

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

Official title: Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure in Intensive Care Unit. A Randomized Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2023-12-15

Completion Date

2028-01-15

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

PROCEDURE

Fluid balance negativation

During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion . When the patient's baseline body weight is reached the UF net will be settled to maintain it. In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min and without tissue hypoperfusion.

PROCEDURE

Body weight Stabilization

During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance. In case of weight stabilisation failure ( variation \>3% after 24h), the UF net can be increased to 1,5 ml/kg/h, as long as high intakes require UFnette at 1.5mL/kg/h to stabilize water balance, with daily reassessment. In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min.

Locations (14)

Centre Hospitalier d'Ajaccio

Ajaccio, France

CHU Amiens-Picardie

Amiens, France

Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon

Bron, France

CHU Caen Normandie

Caen, France

Service de Réanimation, CHU de Dijon

Dijon, France

GHP Saint Joseph Marie Lannelongue

Le Plessis-Robinson, France

CHU Lille - Hôpital Roger Salengro

Lille, France

Hôpital Edouard Herriot, Groupement Hospitalier Centre

Lyon, France

Hôpital de la Croix Rousse

Lyon, France

Hôpital de la Croix Rousse

Lyon, France

Service de Réanimation, Clinique de la Sauvegarde

Lyon, France

Hôpital Edouard Herriot

Lyon, France

Département d'anesthésie réanimation Hôpital Européen Georges Pompidou

Paris, France

Hôpitaux de Bradois - CHRU Nancy

Vandœuvre-lès-Nancy, France