Actively Recruiting
Effects of Variation of Sodium Dialysate in ICU Acute Kidney Injury
Led by University Hospital, Montpellier · Updated on 2025-09-30
158
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research focuses on critically ill patients in the ICU who have acute kidney injury (AKI) and need renal replacement therapy (RRT). It compares two sodium levels in dialysate used during sustained low efficiency daily dialysis-filtration (SLEDD-f) to see their effects on hemodynamic tolerance and fluid overload. The study aims to determine whether a lower sodium level (140 mmol/l) provides similar blood pressure stability during dialysis as a higher level (145 mmol/l) but with less fluid buildup, which is linked to worse outcomes in these patients. Patients in the ICU with AKI requiring RRT will be randomly assigned to receive SLEDD-f with dialysate sodium at either 140 or 145 mmol/l. The dialysis is performed with set parameters including blood flow at 200 ml/min, dialysate flow at 200 ml/min, infusate flow at 60 ml/min, and temperature at 36°C using a polysulfone membrane. Hemodynamic monitoring occurs during each dialysis session. The study is conducted at a single medical ICU and is not blinded to participants or staff. Participants will be closely monitored throughout their ICU stay, with daily assessments of weight, fluid input and output, and extracellular volume to track fluid overload. Researchers will evaluate hemodynamic tolerance during dialysis, fluid overload at 7 and 28 days after starting RRT, ultrafiltration rates, total duration of RRT, ICU length of stay, and mortality at 28 days. The study will last until December 2026 and is sponsored by the University Hospital of Montpellier.
CONDITIONS
Brief Title
Effects of Variation of Sodium Dialysate in ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years old
- Acute kidney injury requiring renal replacement therapy
- Using on line sustained low efficiency daily dialysis-filtration
- SOFA score greater than 5
- Serum sodium level between 135 and 145 mmol/l
You will not qualify if you...
- Chronic kidney disease stage IV or V
- Obstructive acute kidney injury
- Kidney transplant within the year before ICU admission
- Moribund with risk of death within 48 hours
- Vulnerable or protected persons
- Pregnant or breastfeeding mothers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive renal replacement therapy with either a low sodium concentration dialysate (140 mmol/l) or a high sodium concentration dialysate (145 mmol/l) as part of their ICU care for acute kidney injury.
Daily dialysis sessions during treatment
Duration - Up to 28 days after treatment starts
Participants are monitored for fluid overload, ICU length of stay, and survival outcomes up to 28 days after treatment initiation.
Visits as part of ICU stay and monitoring
Trial Site Locations
Total: 1 location
1
Uhmontpellier
Montpellier, Montpellier, France, 34295
Actively Recruiting
Research Team
V
vincent BRUNOT, MD
K
kada KLOUCHE, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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