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RecruitingNCT03329313NADIRAUpdated Sep 30, 2025

Effects of Variation of Sodium Dialysate in ICU

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

Phase
Phase 2
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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

Read the detailed description

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.

02

Conditions studied

  • Acute Kidney Injury
  • Renal Replacement Therapy

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Keywords

  • Intensive care unit
  • SLEDD-f
  • intermittent hemodialysis/diafiltration
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
158 participants (estimated)

Study arms

  • Active comparator
    Low sodium concentration

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

    Drug: Lowering sodium concentration dialysate

  • Sham comparator
    High Sodium Concentration

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

    Drug: Highing sodium concentration dialysate

Interventions

  • DrugLowering sodium concentration dialysate

    Concentration of sodium in dialysate at 140 mmol/l

    Also known as: Concentration of sodium in dialysate at 140 mmol/l

  • DrugHighing sodium concentration dialysate

    Concentration of sodium in dialysate at 145 mmol/l

    Also known as: Concentration of sodium in dialysate at 145 mmol/l

05

What researchers measure

Primary outcomes

  1. 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

  2. Fluid overload

    Daily weight measure from the initiation to the weaning of RRT.

    Time frame: day 28

Secondary outcomes

  1. Intradialytic hemodynamic tolerance

    Intradialytic hemodynamic tolerance

    Time frame: during the requiring renal replacement therapy (RRT)

  2. 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

  3. Fluid overload

    Fluid overload after RRT weaning and ICU stay.

    Time frame: 1 day

  4. Total duration of RRT

    Total duration of RRT at end of hospitalization

    Time frame: 1 day

  5. length of stay

    Length of stay in the service at hospital discharge

    Time frame: 1 day

  6. Mortality rate

    Mortality rate at 28 days of admission

    Time frame: 28 days of admission

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03329313
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Apr 19, 2018
Primary completion
Dec 19, 2026 (estimated)
Completion
Dec 19, 2026 (estimated)
Last update
Sep 30, 2025

Study contacts

vincent BRUNOT, MD
Contact
v-brunot@chu-montpellier.fr
467332495 ext. 33
kada KLOUCHE, MD, PhD
Contact
k-klouche@chu-montpellier.fr
467338441 ext. 33
vincent BRUNOT, MD
principal investigator · University Hospital, Montpellier
aurèle BUZANCAIS, MD
study director · UHNIMES

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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