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

Last updated: November 8, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Nephropathy

Kidney Failure

Treatment

Fluid balance negativation

Body weight Stabilization

Clinical Study ID

NCT05817539
69HCL22_1095
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,

  2. At least 1 organ failure during ICU in addition to AKI (mechanical ventilation oroxygen therapy or vascular filling > 1000ml or vasopressor exposure > 12 hours),

  3. Cumulative UF net less than 2000ml before inclusion,

  4. Norepinephrine < 0,5 µg/kg/min,

  5. Absence of hypoperfusion signs,

  6. Fluid overload defined as follows :

  • fluid overload > 5% of base weight (based on cumulative fluid balance or aweight gain) and/or

  • Obvious oedema of the lumbar region or flanks (oedema > 1cm bucket depth).

Exclusion

Exclusion Criteria:

  1. Chronic renal failure hemodialyzed before admission to the ICU,

  2. Mechanical circulatory support (ECMO, LVAD),

  3. Pregnant, child -bearing age or lactating women,

  4. Stroke less than 30 days,

  5. Intestinal ischemia less than 7 days documented non-operated,

  6. Interventional study participation or exclusion period on going,that may interferewith the present study

  7. Guardianship, curatorship or safeguard of justice,

  8. Absence of signature of free and informed consent by the patient and/or relative,

  9. Patients not affiliated to a social security scheme or beneficiaries of a similarscheme

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Fluid balance negativation
Phase:
Study Start date:
December 15, 2023
Estimated Completion Date:
January 15, 2026

Connect with a study center

  • Centre Hospitalier d'Ajaccio

    Ajaccio, 20090
    France

    Site Not Available

  • Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon

    Bron, 69500
    France

    Active - Recruiting

  • Service de Réanimation, CHU de Dijon

    Dijon, 21000
    France

    Active - Recruiting

  • Service de Réanimation, Hôpital Michallon

    La Tronche, 38700
    France

    Site Not Available

  • Hôpital Edouard Herriot

    Lyon, 69437
    France

    Site Not Available

  • Hôpital Edouard Herriot, Groupement Hospitalier Centre

    Lyon, 69003
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse

    Lyon, 69004
    France

    Active - Recruiting

  • Service Anesthésie Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon

    Lyon, 69003
    France

    Site Not Available

  • Service de Réanimation, Clinique de la Sauvegarde

    Lyon, 69009
    France

    Active - Recruiting

  • Département d'anesthésie réanimation Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Active - Recruiting

  • Service de Réanimation, Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Étienne, 42055
    France

    Site Not Available

  • Hôpitaux de Bradois - CHRU Nancy

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

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