Effects of Variation of Sodium Dialysate in ICU

NCT ID: NCT03329313

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2026-12-19

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low sodium concentration

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

Group Type: ACTIVE_COMPARATOR

Lowering sodium concentration dialysate

Intervention Type: DRUG

Concentration of sodium in dialysate at 140 mmol/l

High Sodium Concentration

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

Group Type: SHAM_COMPARATOR

Highing sodium concentration dialysate

Intervention Type: DRUG

Concentration of sodium in dialysate at 145 mmol/l

Interventions

Lowering sodium concentration dialysate

Concentration of sodium in dialysate at 140 mmol/l

Intervention Type: DRUG

Highing sodium concentration dialysate

Concentration of sodium in dialysate at 145 mmol/l

Intervention Type: DRUG

Other Intervention Names

Concentration of sodium in dialysate at 140 mmol/l; Concentration of sodium in dialysate at 145 mmol/l

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

vincent BRUNOT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

aurèle BUZANCAIS, MD

Role: STUDY_DIRECTOR

UHNIMES

Locations

Uhmontpellier

Montpellier, Montpellier, France

Site Status: RECRUITING

Countries

France

Central Contacts

vincent BRUNOT, MD

Role: CONTACT

v-brunot@chu-montpellier.fr

467332495 ext. 33

kada KLOUCHE, MD, PhD

Role: CONTACT

k-klouche@chu-montpellier.fr

467338441 ext. 33

Facility Contacts

vincent BRUNOT, MD

Role: primary

v-brunot@chu-montpellier.fr

467332495 ext. 33

Other Identifiers

2017-A01704-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL16_0254

Identifier Type: -

Identifier Source: org_study_id