Comparing two dialysis techniques for kidney injury in ICU patients
Comparison of the Effectiveness of Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patients With Acute Renal Injury : a Monocentric Controled Randomized Non Inferiority Open Labeled Study
This study is testing whether a new dialysis method using citrate is just as good as a traditional method using heparin for helping ICU patients with kidney injury lower their urea levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT06369064 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of continuous venovenous hemodialysis (CVVHD) and continuous venovenous hemodiafiltration (CVVHDF) in reducing urea levels in patients with acute kidney injury in the intensive care unit. Both techniques are commonly used for renal replacement therapy, but there is limited evidence comparing their efficacy at equivalent dialysis doses. The research will assess whether the citrate-based CVVHD is as effective as the heparin-based CVVHDF in achieving urea reduction, which is crucial for managing patients' overall health during treatment. The study will involve adult ICU patients who meet specific criteria for renal replacement therapy.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients with stage 3 acute kidney injury requiring renal replacement therapy.
Not a fit: Patients with end-stage chronic kidney disease or those requiring emergency dialysis for specific contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for optimizing dialysis techniques, potentially improving patient outcomes in acute kidney injury management.
How similar studies have performed: While there have been limited studies comparing these techniques, this study aims to fill a gap in the evidence base, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Adult patients hospitalized in ICU * Undergo RRT session because of AKI stage 3 * At least one among criteria: pH \< 7,20 / Blood urea \> 30mM / Fluid overload uncontrolled by diuretics. * Patient having given free and informed consent, and having signed the consent form or patient included in an emergency situation * Patient affiliated with Social Security. Exclusion criteria: * End-stage chronic kidney disease on dialysis * Intoxication with a dialyzable toxin (lithium * Criteria for emergency dialysis initiation: hyperkaliemia \>6,5mM with electrocardiographic signs * Medical contraindication to regional citrate: severe liver failure * Medical contraindication to anticoagulation or heparin anticoagulation: heparin induced thrombopenia or uncontrolled bleeding * Pregnant women, parturient or breast-feeding patient
Where this trial is running
Nîmes
- CHU de Nimes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Claire Roger — CHU Nimes
- Study coordinator: Claire Roger, MD
- Email: Claire.roger@chu-nimes.fr
- Phone: 04.66.68.30.50
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.