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Recruiting Phase 2

Effects of Variation of Sodium Dialysate in ICU

NCT03329313 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2018-04-19
Last updated
2025-09-30

Condition(s) studied

Acute Kidney InjuryRenal Replacement Therapy

Investigational drug(s) / intervention(s)

Lowering sodium concentration dialysateHighing sodium concentration dialysate

Lowering sodium concentration dialysate: Concentration of sodium in dialysate at 140 mmol/l

Highing sodium concentration dialysate: Concentration of sodium in dialysate at 145 mmol/l

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Fluid overload — 7 days after the initiation of renal replacement therapy
    Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.
  • Fluid overload — day 28
    Daily weight measure from the initiation to the weaning of RRT.

Trial sites (1)

FacilityCityRegionStatus
Uhmontpellier Montpellier Montpellier Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03329313 on ClinicalTrials.gov ↗ ← All trials in France