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Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Sponsor: Hospices Civils de Lyon
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
Conditions
Interventions
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.
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