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

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

Conditions

• Acute Kidney Injury
• Fluid Overload

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.

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-15

Primary Completion

2028-01-15

Completion

2028-01-15

Countries

• France

Study Locations