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NCT03329313: NADIRA
Effects of Variation of Sodium Dialysate in ICU
Phase 2 trial testing Lowering sodium concentration dialysate in Acute Kidney Injury in 158 participants. Currently enrolling.
19 December 2026
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 158 |
| Start date | 19 April 2018 |
| Primary completion | 19 December 2026 |
| Estimated completion | 19 December 2026 |
| Sites | 1 location across France |
Drugs / interventions tested
- Lowering sodium concentration dialysate — full drug profile →
- Highing sodium concentration dialysate — full drug profile →
Conditions studied
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
- Renal Replacement Therapy — all drugs for Renal Replacement Therapy →
Sponsor
University Hospital, Montpellier
Who can join
Adults 18 to 80, any sex, with Acute Kidney Injury or Renal Replacement Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Perioperative Acute Kidney Injury.
Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968 -
Nanotechnology-Enhanced Extracellular Vesicles -Based Chipsets in Early Cancer Detection and Theranostics.
Maitra S, Sarkar S, Chandra M, Ballal S, et al · · 2025 · cited 1× · PMID 40837698 · DOI 10.2147/ijn.s529128
Verify or expand the search:
- PubMed search for NCT03329313
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03329313 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 30 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03329313.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing