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Effects of Variation of Sodium Dialysate in ICU

Study acronym: NADIRA
StatusRecruiting
PhasePhase 2
Started2018-04-19
View on ClinicalTrials.gov ↗

Amendment history

2025-09-24
minor
Study Identification, Study Status, Oversight, Contacts/Locations v6
Primary completion date2024-12-19→2026-12-19
Completion date2025-12-19→2026-12-19
Study sitesdetails revised at 1 of 1 site
2024-07-15
minor
Study Status v5
Primary completion date2024-12→2024-12-19
Completion date2025-12→2025-12-19
2023-12-04
minor
Study Status v4
Primary completion date2023-05→2024-12
Completion date2024-06→2025-12
2022-09-16
minor
Study Status v3
Primary completion date2022-12-31→2023-05
Completion date2023-06-01→2024-06
2022-01-18
minor
Study Status v2
Primary completion date2020-12-31→2022-12-31
Completion date2021-06-01→2023-06-01
2018-04-19
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-11-01→confirmed 2018-04-19
Study sitesdetails revised at 1 of 1 site
2017-10-27
minor
Original filing
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
Trial Details
NCT Number NCT03329313
Lead Sponsor University Hospital, Montpellier
Conditions Acute Kidney Injury, Renal Replacement Therapy
Enrollment 158 participants
Start Date 2018-04-19
Primary Completion 2026-12-19 (estimated)
Study Completion 2026-12-19 (estimated)
Updated on ClinicalTrials.gov 2025-09-30