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

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 or oxygen therapy or vascular filling \> 1000ml or vasopressor exposure \> 12 hours), 3. Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion, 4. Norepinephrine \< 0,5 µg/kg/min, 5. Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria: * TRC \> 3s at the finger * Marbrure score \> 2 * Lactate \> 2 mmol/L * ScVO2\< 60%, 6. 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). 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 based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, 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 interfere with 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 similar scheme
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What it tests

  • Fluid balance negativation
  • Body weight Stabilization
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Where

14 sites
Centre Hospitalier d'Ajaccio
Ajaccio, France
CHU Amiens-Picardie
Amiens, France
Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
Bron, France
CHU Caen Normandie
Caen, France
Service de Réanimation, CHU de Dijon
Dijon, France
GHP Saint Joseph Marie Lannelongue
Le Plessis-Robinson, France
CHU Lille - Hôpital Roger Salengro
Lille, France
Hôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, France

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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