Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
- Conditions
- Acute Kidney InjuryFluid Overload
- Interventions
- Procedure: Fluid balance negativationProcedure: Body weight Stabilization
- Registration Number
- NCT05817539
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
-
Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
-
At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or oxygen therapy or vascular filling > 1000ml or vasopressor exposure > 12 hours),
-
Cumulative UF net less than 2000ml before inclusion,
-
Norepinephrine < 0,5 µg/kg/min,
-
Absence of hypoperfusion signs,
-
Fluid overload defined as follows :
- fluid overload > 5% of base weight (based on cumulative fluid balance or a weight gain) and/or
- Obvious oedema of the lumbar region or flanks (oedema > 1cm bucket depth).
- Chronic renal failure hemodialyzed before admission to the ICU,
- Mechanical circulatory support (ECMO, LVAD),
- Pregnant, child -bearing age or lactating women,
- Stroke less than 30 days,
- Intestinal ischemia less than 7 days documented non-operated,
- Interventional study participation or exclusion period on going,that may interfere with the present study
- Guardianship, curatorship or safeguard of justice,
- Absence of signature of free and informed consent by the patient and/or relative,
- Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Corrective strategy Fluid balance negativation In the experimental group, all patients will have a UFnet settled (2 ml/kg/h ) in order to reach the patient baseline body weight. Stabilizing strategy Body weight Stabilization In the control group, all patients will have a UFnet 2 ml settled (0 to 1 ml/kg/h) in order to stabilize the patient body weight.
- Primary Outcome Measures
Name Time Method Number of organ replacement free-days Day 30 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.
- Secondary Outcome Measures
Name Time Method Mortality decrease 30 days Number of deaths
Incidence of strokes From Day 0 to Day 30 Number of ischemic strokes occurrence on imagery
Renal recovery assessment Day 30 Renal recovery is defined according to MAKE 30 scale :
* Survival
* Absence of renal replacement therapy
* Day 30 creatinine level \< baseline creatinine x 200 %Incidence of arrhythmias and cardiac conduction disorders in both group From Day 0 up to Day 5 Number of arrhythmias and cardiac conduction disorders occurrence on ECG
Incidence of intestinal ischemia in both group From Day 0 to Day 30 Number of intestinal ischemia on CT scan or endoscopy
Incidence of delirium Between Day 0 and Day 5 Presence of delirium assessed with the CAM ICU scale : positive or negative score. A positive score means presence of delirium
Number of renal replacement therapy-free days increase Day 30 Number of renal replacement therapy-free days
Number of ventilator-free day increase Day 30 Number of ventilator-free day
Number of vasopressor-free day increase Day 30 Number of vasopressor-free day
Duration of intensive care unit stay Up to Day 30 Number of days in ICU
SOFA score evolution From Day 0 up to Day 5 SOFA score : Sepsis-related Organ Failure Assessment, min : 0 max : 24 (worse)
Trial Locations
- Locations (9)
Hôpitaux de Bradois - CHRU Nancy
🇫🇷Vandœuvre-lès-Nancy, France
Centre Hospitalier d'Ajaccio
🇫🇷Ajaccio, France
Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
🇫🇷Bron, France
Service de Réanimation, CHU de Dijon
🇫🇷Dijon, France
Hôpital Edouard Herriot, Groupement Hospitalier Centre
🇫🇷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