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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Centre Hospitalier d'Ajaccio
NOT_YET_RECRUITING
Ajaccio
Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
RECRUITING
Bron
Service de Réanimation, CHU de Dijon
RECRUITING
Dijon
Hôpital de la Croix Rousse
NOT_YET_RECRUITING
Lyon
Hôpital de la Croix Rousse
RECRUITING
Lyon
Hôpital Edouard Herriot
NOT_YET_RECRUITING
Lyon
Hôpital Edouard Herriot, Groupement Hospitalier Centre
RECRUITING
Lyon
Service de Réanimation, Clinique de la Sauvegarde
RECRUITING
Lyon
Département d'anesthésie réanimation Hôpital Européen Georges Pompidou
RECRUITING
Paris
Hôpitaux de Bradois - CHRU Nancy
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Matthias JACQUET LAGREZE, MD PhD
Matthias.jacquet-lagreze@chu-lyon.fr
04 72 35 79 41
Backup
Julia CANTERINI, project manager
Julia.canterini@chu-lyon.fr
04 27 85 66 28
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 250
Treatments
Experimental: Corrective strategy
In the experimental group, all patients will have a UFnet settled (2 ml/kg/h ) in order to reach the patient baseline body weight.
Other: Stabilizing strategy
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.
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov