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Acute Kidney InjuryPhase 2NADIRANCT03329313

Effects of Variation of Sodium Dialysate in ICU

A Phase 2 study testing Lowering sodium concentration dialysate and Highing sodium concentration dialysate in people with Acute Kidney Injury and Renal Replacement Therapy, run by University Hospital, Montpellier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lowering sodium concentration dialysate and Highing sodium concentration dialysate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
1 siteFrance
Study dates
19 Apr 2018to 19 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Uhmontpellier

    Montpellier, Montpellier, 34295

    vincent BRUNOT, MD, 467332495 ext. 33, v-brunot@chu-montpellier.fr

    Recruiting

Other trials in France

About this study

Official title: Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury

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.

Being tested
Lowering sodium concentration dialysate, Highing sodium concentration dialysate
Keywords
Intensive care unit, SLEDD-f, intermittent hemodialysis/diafiltration
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lowering sodium concentration dialysateDrug

    Also called Concentration of sodium in dialysate at 140 mmol/l

    Concentration of sodium in dialysate at 140 mmol/l

  • Highing sodium concentration dialysateDrug

    Also called Concentration of sodium in dialysate at 145 mmol/l

    Concentration of sodium in dialysate at 145 mmol/l

Study groups in NCT03329313
Study groupRoleWhat they receive
Low sodium concentrationActive comparatorConcentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate)
Receives: Drug: Lowering sodium concentration dialysate
High Sodium ConcentrationSham comparatorConcentration of sodium in dialysate at 145 mmol/l (Highing sodium concentration dialysate)
Receives: Drug: Highing sodium concentration dialysate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluid overload

    Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.

    Measured: 7 days after the initiation of renal replacement therapy

  2. Fluid overload

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

    Measured: day 28

Secondary outcomes (6)
  1. Intradialytic hemodynamic tolerance

    Intradialytic hemodynamic tolerance

    Measured: 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

    Measured: 1 day

  3. Fluid overload

    Fluid overload after RRT weaning and ICU stay.

    Measured: 1 day

  4. Total duration of RRT

    Total duration of RRT at end of hospitalization

    Measured: 1 day

  5. length of stay

    Length of stay in the service at hospital discharge

    Measured: 1 day

  6. Mortality rate

    Mortality rate at 28 days of admission

    Measured: 28 days of admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start19 Apr 2018
  3. Primary completion19 Dec 2026 (estimated)
  4. Study completion19 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03329313
Sponsor's protocol ID
RECHMPL16_0254
Other IDs
2017-A01704-49
Acronym
NADIRA
Status last verified
Sep 2025
First submitted
7 Sep 2017
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lowering sodium concentration dialysate and Highing sodium concentration dialysate in people with Acute Kidney Injury and Renal Replacement Therapy, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact vincent BRUNOT, MD (467332495 ext. 33, v-brunot@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid overload (time frame: 7 days after the initiation of renal replacement therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.

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