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.
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
- Conditions the study is for
- Acute Kidney Injury, Renal Replacement Therapy
- 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
- Recruiting
Uhmontpellier
Montpellier, Montpellier, 34295
vincent BRUNOT, MD, 467332495 ext. 33, v-brunot@chu-montpellier.fr
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.
- Conditions
- Acute Kidney Injury, Renal Replacement Therapy
- 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 group | Role | What they receive |
|---|---|---|
| Low sodium concentration | Active comparator | Concentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate) Receives: Drug: Lowering sodium concentration dialysate |
| High Sodium Concentration | Sham comparator | Concentration 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.
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
Fluid overload
Daily weight measure from the initiation to the weaning of RRT.
Measured: day 28
Secondary outcomes (6)
Intradialytic hemodynamic tolerance
Intradialytic hemodynamic tolerance
Measured: 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
Measured: 1 day
Fluid overload
Fluid overload after RRT weaning and ICU stay.
Measured: 1 day
Total duration of RRT
Total duration of RRT at end of hospitalization
Measured: 1 day
length of stay
Length of stay in the service at hospital discharge
Measured: 1 day
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.
- First posted1 Nov 2017
- Study start19 Apr 2018
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- vincent BRUNOT, MD, Principal investigator, University Hospital, Montpellieraurèle BUZANCAIS, MD, Study director, UHNIMES
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury
- ClinicalTrials.gov ID
- NCT03329313
- Acronym / sponsor ID
- NADIRA / RECHMPL16_0254
- Conditions
- Acute Kidney Injury, Renal Replacement Therapy
- Keywords
- Intensive care unit, SLEDD-f, intermittent hemodialysis/diafiltration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low sodium concentration | Active comparator | Drug: Lowering sodium concentration dialysateConcentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate) |
| High Sodium Concentration | Sham comparator | Drug: Highing sodium concentration dialysateConcentration of sodium in dialysate at 145 mmol/l (Highing sodium concentration dialysate) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lowering sodium concentration dialysateAlso: Concentration of sodium in dialysate at 140 mmol/lConcentration of sodium in dialysate at 140 mmol/l | Drug | Low sodium concentration |
| Highing sodium concentration dialysateAlso: Concentration of sodium in dialysate at 145 mmol/lConcentration of sodium in dialysate at 145 mmol/l | Drug | High Sodium Concentration |
Primary outcome
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.
Fluid overload
Time frame: day 28
Daily weight measure from the initiation to the weaning of RRT.
6 secondary outcomes
Intradialytic hemodynamic tolerance
Time frame: during the requiring renal replacement therapy (RRT)
Mean ultrafiltration rate by patient/ session
Time frame: 1 day
Fluid overload
Time frame: 1 day
Total duration of RRT
Time frame: 1 day
length of stay
Time frame: 1 day
Mortality rate
Time frame: 28 days of admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
vincent BRUNOT, MD principal investigator
University Hospital, Montpellier
aurèle BUZANCAIS, MD study director
UHNIMES
1 site in 1 country: see every site and its status.
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.