Effects of Variation of Sodium Dialysate in ICU (NADIRA)

September 24, 2025 updated by: University Hospital, Montpellier

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • France
    • Montpellier
      • Montpellier, Montpellier, France, 34295

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Low sodium concentration
Concentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate)
Drug: Lowering sodium concentration dialysate
Concentration of sodium in dialysate at 140 mmol/l
Other Names:
  • Concentration of sodium in dialysate at 140 mmol/l
Sham Comparator: High Sodium Concentration
Concentration of sodium in dialysate at 145 mmol/l (Highing sodium concentration dialysate)
Drug: Highing sodium concentration dialysate
Concentration of sodium in dialysate at 145 mmol/l
Other Names:
  • Concentration of sodium in dialysate at 145 mmol/l

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fluid overload
Time Frame: 7 days after the initiation of renal replacement therapy
Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.
7 days after the initiation of renal replacement therapy
Fluid overload
Time Frame: day 28
Daily weight measure from the initiation to the weaning of RRT.
day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intradialytic hemodynamic tolerance
Time Frame: during the requiring renal replacement therapy (RRT)
Intradialytic hemodynamic tolerance
during the requiring renal replacement therapy (RRT)
Mean ultrafiltration rate by patient/ session
Time Frame: 1 day
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
1 day
Fluid overload
Time Frame: 1 day
Fluid overload after RRT weaning and ICU stay.
1 day
Total duration of RRT
Time Frame: 1 day
Total duration of RRT at end of hospitalization
1 day
length of stay
Time Frame: 1 day
Length of stay in the service at hospital discharge
1 day
Mortality rate
Time Frame: 28 days of admission
Mortality rate at 28 days of admission
28 days of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: vincent BRUNOT, MD, University Hospital, Montpellier
  • Study Director: aurèle BUZANCAIS, MD, UHNIMES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL16_0254
  • 2017-A01704-49 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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