Managing fluid overload in ICU patients with acute kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates an early deresuscitation strategy aimed at correcting fluid overload in ICU patients suffering from acute kidney injury who are undergoing renal replacement therapy. The approach focuses on optimizing fluid balance through net ultrafiltration, which is believed to improve patient outcomes by reducing morbidity and mortality associated with fluid overload. The study will assess the effectiveness of a moderate ultrafiltration rate in comparison to standard practices, with the goal of enhancing kidney recovery and minimizing complications. Patients will be closely monitored for signs of hypoperfusion and other adverse effects during the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Hospitalier d'Ajaccio
  Ajaccio, France Recruiting
• CHU Amiens-Picardie
  Amiens, France Recruiting
• Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
  Bron, France Recruiting
• Service de Réanimation, CHU de Dijon
  Dijon, France Recruiting
• GHP Saint Joseph Marie Lannelongue
  Le Plessis-Robinson, France Recruiting
• CHU Lille - Hôpital Roger Salengro
  Lille, France Recruiting

Study contacts

• Study coordinator: Matthias JACQUET LAGREZE, MD PhD
• Email: Matthias.jacquet-lagreze@chu-lyon.fr
• Phone: 04 72 35 79 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.