Managing fluid overload in ICU patients with acute kidney injury

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

This study tests a new way to manage extra fluid in ICU patients with kidney problems to see if it helps them recover better and have fewer complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 14 sites (Ajaccio and 13 other locations)
• Trial ID: NCT05817539 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include ICU patients with acute kidney injury treated by continuous renal replacement therapy who exhibit signs of fluid overload.

Not a fit: Patients with chronic renal failure on hemodialysis prior to ICU admission or those requiring mechanical circulatory support will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality and improve recovery rates in patients with acute kidney injury undergoing renal replacement therapy.

How similar studies have performed: Previous studies have suggested that managing fluid overload can lead to improved outcomes, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Ajaccio and 13 other locations

• Centre Hospitalier d'Ajaccio — Ajaccio, France (Not_yet_recruiting)
• CHU Amiens-Picardie — Amiens, France (Not_yet_recruiting)
• Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon — Bron, France (Recruiting)
• CHU Caen Normandie — Caen, France (Not_yet_recruiting)
• Service de Réanimation, CHU de Dijon — Dijon, France (Recruiting)
• GHP Saint Joseph Marie Lannelongue — Le Plessis-Robinson, France (Not_yet_recruiting)
• CHU Lille - Hôpital Roger Salengro — Lille, France (Not_yet_recruiting)
• Hôpital Edouard Herriot, Groupement Hospitalier Centre — Lyon, France (Recruiting)
• Hôpital de la Croix Rousse — Lyon, France (Not_yet_recruiting)
• Hôpital de la Croix Rousse — Lyon, France (Recruiting)
• Service de Réanimation, Clinique de la Sauvegarde — Lyon, France (Recruiting)
• Hôpital Edouard Herriot — Lyon, France (Not_yet_recruiting)
• Département d'anesthésie réanimation Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
• Hôpitaux de Bradois - CHRU Nancy — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Matthias JACQUET LAGREZE, MD PhD

Conditions Acute Kidney Injury; Fluid Overload; Renal Replacement Therapy; Ultrafiltration; Deresuscitation; Fluid balance; Fluid overload; Tissue perfusion