Comparing sodium levels in dialysis for ICU patients with kidney injury
Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury
PHASE2 · University Hospital, Montpellier · NCT03329313
This study is testing if using a lower sodium level in dialysis can help ICU patients with kidney injury feel more stable and avoid extra fluid buildup.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier, Montpellier) |
| Trial ID | NCT03329313 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different sodium concentrations in dialysate on hemodynamic tolerance and fluid overload in ICU patients suffering from acute kidney injury (AKI) requiring renal replacement therapy. The study compares two groups of patients receiving sustained low efficiency daily dialysis-filtration (SLEDD-f) with dialysate sodium concentrations of 140 mmol/l and 145 mmol/l. The goal is to determine if a lower sodium concentration can maintain hemodynamic stability while reducing the risk of fluid overload, which is associated with higher mortality in critically ill patients. Participants will be monitored over a 7-day period to assess their response to the different sodium levels.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with acute kidney injury requiring renal replacement therapy and a SOFA score greater than 5.
Not a fit: Patients with chronic kidney disease stage IV or V, obstructive acute kidney injury, or those who are moribund with a high risk of death within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dialysis protocols that enhance patient safety and outcomes in critically ill patients with AKI.
How similar studies have performed: Previous studies have indicated that varying dialysate sodium concentrations can impact hemodynamic tolerance, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age \> 18 years old * Acute kidney injury requiring renal replacement therapy * Dialysis type: on line sustained low efficiency dialy dialysis -filtration * SOFA score \> 5 * Sodium serum level between 135 and 145mmol/l Exclusion criteria: * Chronic kidney disease stade IV ou V * Obstrutive acute kidney injury * Renal tansplantation in the year before ICU admission * Moribund with risk of death in the 48 hours * Vulnerable persons or protected persons * Pregnant or breastfeeding mother
Where this trial is running
Montpellier, Montpellier
- Uhmontpellier — Montpellier, Montpellier, France (RECRUITING)
Study contacts
- Principal investigator: vincent BRUNOT, MD — University Hospital, Montpellier
- Study coordinator: vincent BRUNOT, MD
- Email: v-brunot@chu-montpellier.fr
- Phone: 467332495
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.
Conditions: Acute Kidney Injury, Renal Replacement Therapy, Intensive care unit, SLEDD-f, intermittent hemodialysis/diafiltration