Effects of different fluid removal rates during kidney treatment
Evaluation of the Hemodynamic Effect of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy Sessions for Acute Renal Failure in Intensive Care Patients. Multiple N-of-1 Randomised Bi-centric Controlled Trial.
This study is testing different fluid removal rates during kidney treatment to see which one helps patients with acute kidney injury feel more stable while managing their fluid levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nimes) |
| Trial ID | NCT06071026 on ClinicalTrials.gov |
What this trial studies
This study investigates the hemodynamic effects of varying net ultrafiltration rates during continuous renal replacement therapy (RRT) in patients with acute kidney injury. It aims to compare three specific rates: 1 ml/kg/h, 2 ml/kg/h, and 3 ml/kg/h, to determine which rate minimizes hemodynamic instability while effectively managing fluid balance. The research is motivated by the lack of established guidelines for setting net ultrafiltration rates, which are crucial for patient outcomes in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates include ICU patients diagnosed with acute kidney injury requiring continuous renal replacement therapy and exhibiting signs of fluid overload.
Not a fit: Patients who are hemodynamically unstable or do not require fluid removal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of fluid overload in critically ill patients, potentially reducing complications and mortality.
How similar studies have performed: While there is limited prospective research on this specific approach, the study addresses a critical gap in current clinical practice regarding net ultrafiltration rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients hospitalised in the intensive care unit of one of the two participating centres * Patients with Kidney Disease: Improving Global Outcomes 3 (KDIGO3) acute kidney injury (AKI) requiring a continuous RRT during their stay in the intensive care unit, regardless of the aetiology of the AKI * Need to prescribe water loss by net ultrafiltration (NUF), defined by at least one of the following sub-criteria: 1. weight gain ≥ 1 kg relative to entry weight 2. oligo-anuria ≥ 24 hours 3. clinical impact of fluid overload as judged by the clinician: acute lung oedema clinical or at CT-scan, difficulty of weaning from mechanical ventilation. * Hemodynamic stability in the 2 hours preceding the start of NUF, defined by all of the following sub-criteria: 1. absence of vasopressors (noradrenaline) or stability or reduction in their dosage 2. no need for resuscitative fluids as judged by the clinician * Patient or his/her trusted support person/legal representative/family member having given free and informed consent, and having signed the consent form or patient included in an emergency situation. * Patient affiliated to or benefiting from a health insurance scheme. Exclusion Criteria: * Patient moribund, with life expectancy too low to benefit from treatment, or with decision to discontinue treatment * Patient participating in an another interventional study * Patient in exclusion period determined by another study * Patient under court protection or guardianship * Patient/trusted person/legal representative/family member for whom it is impossible to give informed information. * Pregnant, parturient or breast-feeding patient.
Where this trial is running
Nimes
- Centre Hospitalier Universitaire de Nîmes — Nimes, France (Recruiting)
Study contacts
- Principal investigator: Saber D. BARBAR, MD, PhD — Centre Hospitalier Universitaire de Nīmes
- Study coordinator: Saber D. BARBAR, MD, PhD
- Email: saber.barbar@chu-nimes.fr
- Phone: 0033 4 66 68 33 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.