NCT03329313 Effects of Variation of Sodium Dialysate in ICU
| NCT ID | NCT03329313 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Montpellier |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2018-04-19 |
| Primary Completion | 2026-12-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 158 participants in total. It began in 2018-04-19 with a primary completion date of 2026-12-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Intermittent hemodialysis/diafiltration is a current renal replacement therapy (RRT) institued for ICU patients with AKI. For a better clinical tolerance, iinternational guidelines advise to use cold dialysate, increase duration session, decrease blood and dialysate flows, and increase level of sodium dialysate concentration (≥ 145mmol/l). Indeed, the use of a Na concentration dialysate \> 145 mmol/l improves intradialytic hemodynamic tolerance but it may also induce fluid overload by the transfert of sodium from the dialysate compartment to the blood. Yet, fluid overload has been strongly associated with mortality in critically ills. The investigators hypothesized that the use of a level in sodium dialysate at 140 mmol/l with slow low efficiency daily dialysis-filtration (SLEDD-f) will permit a fair intradialytic hemodynamic tolerance without the adverse effect of intradiaclytic Na loading from the dialysate. Two randomized groups of ICU AKI patients treated by SLEDD-f will be compared in terms of intradialytic hemodynamic tolerance and overload accordong to 140 or 145 mmol/l of Na in the dialysate
Eligibility 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
Contact & Investigator
vincent BRUNOT, MD
PRINCIPAL INVESTIGATOR
University Hospital, Montpellier
Frequently Asked Questions
Who can join the NCT03329313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03329313 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03329313 currently recruiting?
Yes, NCT03329313 is actively recruiting participants. Contact the research team at v-brunot@chu-montpellier.fr for enrollment information.
Where is the NCT03329313 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT03329313 clinical trial?
NCT03329313 is sponsored by University Hospital, Montpellier. The principal investigator is vincent BRUNOT, MD at University Hospital, Montpellier. The trial plans to enroll 158 participants.
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