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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
250
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.
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.
Centre Hospitalier d'Ajaccio
Ajaccio, France
NOT_YET_RECRUITINGCHU Amiens-Picardie
Amiens, France
NOT_YET_RECRUITINGService d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, France
RECRUITINGCHU Caen Normandie
Caen, France
NOT_YET_RECRUITINGService de Réanimation, CHU de Dijon
Dijon, France
RECRUITINGGHP Saint Joseph Marie Lannelongue
Le Plessis-Robinson, France
NOT_YET_RECRUITINGCHU Lille - Hôpital Roger Salengro
Lille, France
NOT_YET_RECRUITINGHôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, France
RECRUITINGHôpital de la Croix Rousse
Lyon, France
NOT_YET_RECRUITINGHôpital de la Croix Rousse
Lyon, France
RECRUITING...and 4 more locations
Number of organ replacement free-days
Number of organ replacement free-days, i.e, number of renal replacement therapy-free days, number of vasopressor-free days, number of ventilator-free day. Number of days between 2 same type organ replacement interruption is not counted. In case of death before 30 days, number of days is censored to 0.
Time frame: Day 30
Mortality decrease
Number of deaths
Time frame: 30 days
Number of renal replacement therapy-free days increase
Number of renal replacement therapy-free days
Time frame: Day 30
Number of ventilator-free day increase
Number of ventilator-free day
Time frame: Day 30
Number of vasopressor-free day increase
Number of vasopressor-free day
Time frame: Day 30
Duration of intensive care unit stay
Number of days in ICU
Time frame: Up to Day 30
SOFA score evolution
SOFA score : Sepsis-related Organ Failure Assessment, min : 0 max : 24 (worse)
Time frame: From Day 0 up to Day 5
Incidence of arrhythmias and cardiac conduction disorders in both group
Number of arrhythmias and cardiac conduction disorders occurrence on ECG
Time frame: From Day 0 up to Day 5
Incidence of intestinal ischemia in both group
Number of intestinal ischemia on CT scan or endoscopy
Time frame: From Day 0 to Day 30
Incidence of strokes
Number of ischemic strokes occurrence on imagery
Time frame: From Day 0 to Day 30
Incidence of delirium
Presence of delirium assessed with the CAM ICU scale : positive or negative score. A positive score means presence of delirium
Time frame: Between Day 0 and Day 5
Renal recovery assessment
Renal recovery is defined according to MAKE 30 scale : * Survival * Absence of renal replacement therapy * Day 30 creatinine level \< baseline creatinine x 200 %
Time frame: Day 30
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