A Phase 2 interventional study of Lowering sodium concentration dialysate and Highing sodium concentration dialysate in Acute Kidney Injury and Renal Replacement Therapy, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by University Hospital, Montpellier · Phase 2, Interventional, and Treatment
Among 154 studies in Acute Kidney Injury with a site in France — 31 open to participants now, 35 under way, 4 of them phase 3. Acute Kidney Injury · France.
Among the 154 studies in Acute Kidney Injury with a site in France, this one is the 37th largest by planned enrollment of the 78 interventional ones that give a count, is one of 11 that started in 2018, is one of 8 in phase 2, reaches primary completion later than 17 of the 34 other live ones, and was the 47th registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 394 are open to participants now.
Browse Acute Kidney Injury studies →31 of the 154 studies in Acute Kidney Injury with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire de Nīmes · Sites in France
Ages 18+
Uppsala University · Sites in France, Australia, Brazil and 7 more countries
Ages 0–16
AstraZeneca · Sites in France, United States, Argentina and 11 more countries
Ages 18–80
Hospices Civils de Lyon · Sites in France
Ages 18+
University Hospital, Bordeaux · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 22 · Phase 4 5
First in 2004; this study’s year is marked. 11 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 158 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Median enrollment 150 across the 78 interventional studies, 190 across the 76 observational. Of the 105 that completed or were terminated, 8 (8%) have results posted.
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13 of 154 have an industry lead sponsor. The 10 most frequent:
University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
University Hospital, Montpellier has 9 studies filed under Acute Kidney Injury — fewer than ten, so there is no comparison to draw.
11 of the studies in Acute Kidney Injury with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03329313University Hospital, MontpellierEffects of Variation of Sodium Dialysate in ICU | 2026-12-19 |
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT04264065Assistance Publique - Hôpitaux de ParisAlbumin and Prognosis of Severely Patients Burns | 2027-01-16 |
| NCT07215702AstraZenecaA Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. | 2027-02-11 |
| NCT07596407Assistance Publique - Hôpitaux de ParisAcute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment | 2027-05-30 |
Add all 11 to your calendar (.ics) → With an account.
Among the 154 studies in Acute Kidney Injury with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
Acute kidney injury (AKI) requiring renal replacement therapy (RRT) occurs in 5 to 6% of critically ill patients and is associated with high mortality and significant health resource utilization. Modalities of RRT currently available include intermittent hemodialysis/diafiltration (IHD/F) and continuous renal replacement therapies. Continuous veno-venous therapies have gained wide application in ICUs, often supplanting IHD because of the belief that it is better tolerated in hemodynamically unstable patients. Previous reports have shown however that intermittent therapies may permit similar hemodynamic tolerance but with specific parameters including dialysate composition. Consequently, international guidelines suggest in ICU AKI the use of intermittent modalities with the use of cold dialysate, increased duration session, decreased blood and dialysate flows, and high level of sodium dialysate concentration (≥ 145mmol/l). Increasing the level of sodium dialysate concentration improves obviously the hemodynamic tolerance but may also result in inflated extracellular volume and fluid overload secondary to sodium transfert from the dialysate compartment to the blood. There is a body of evidence that fluid overload may be harmful to the critically ill, has an adverse impact and worsens outcome.
The aim of the study is therefore to compare perdialytic hemodynamic tolerance and fluid overload after 7 days of SLEDD-f using 2 sodium dialysate concentrations -140 vs 145 mmol/l- in ICU AKI patients. The investigators also planned to evaluate and compare mean ultrafiltration rate by patient, total duration of RRT, fluid overload at RRT weaning, ICU length of stay and 28 days ICU mortality using these 2 levels of sodium dialysate concentration.
Methods: This randomised, single center, prospective and non blinded study is being held in medical ICU at Lapeyronie University Hospital of Montpellier.
Patient more than 18 years old, admitted to the ICU for AKI requiring RRT and with a sSofa score > 5 will be included.
RRT will be an on line predilution SLEDD- with the following parameters: blood flow 200ml/min, dialysate flow 200ml/min, infusate flow 60ml/min, temperature 36°C, membrane polysulfone Fx80. An hemodynamic monitoring will be performed at each dialysis session. Weight, daily input and output and extracellular volume will be monitored during ICU stay.
According to the sodium concentration dialysate: 140 or 145 mmol/l, 2 groups will be randomized and compared regarding to hemodynamic tolerance, fluid overload and outcome.
Hypothesis: The use of a sodium dialysate concentration at 140 mmol/l with SLEDD-f will induce a similar intradialytic hemodynamic tolerance as compared to a Na dialysate at 145 mmmol/l but with a decrease at around 4% of fluid overload.
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Exclusion criteria:
Concentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate)
Drug: Lowering sodium concentration dialysate
Concentration of sodium in dialysate at 145 mmol/l (Highing sodium concentration dialysate)
Drug: Highing sodium concentration dialysate
Concentration of sodium in dialysate at 140 mmol/l
Also known as: Concentration of sodium in dialysate at 140 mmol/l
Concentration of sodium in dialysate at 145 mmol/l
Also known as: Concentration of sodium in dialysate at 145 mmol/l
Fluid overload
Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.
Time frame: 7 days after the initiation of renal replacement therapy
Fluid overload
Daily weight measure from the initiation to the weaning of RRT.
Time frame: day 28
Intradialytic hemodynamic tolerance
Intradialytic hemodynamic tolerance
Time frame: during the requiring renal replacement therapy (RRT)
Mean ultrafiltration rate by patient/ session
Appreciation of ultrafiltration rate for each patient and for each RRT session for all the renal replacement therapy. Calcultate the mean ultrafiltration rate by patient. Daily Weight measurement before and after each RRT session and daily
Time frame: 1 day
Fluid overload
Fluid overload after RRT weaning and ICU stay.
Time frame: 1 day
Total duration of RRT
Total duration of RRT at end of hospitalization
Time frame: 1 day
length of stay
Length of stay in the service at hospital discharge
Time frame: 1 day
Mortality rate
Mortality rate at 28 days of admission
Time frame: 28 days of admission
Plan to share: Undecided — NC
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Dec 2026, 104 months after the start.
Of 39 non-industry phase 2 interventional studies under Acute Kidney Injury, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 42. This study's planned 104 months is above that.
Counting every sponsor, half of 57 studies reached it within 29 months; a quarter within 16 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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University Hospital, Montpellier →