Effects of Variation of Sodium Dialysate in ICU

NCT03329313 | Recruiting Phase 2

• 2 other identifiers: RECHMPL16_02542017-A01704-49
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury; Renal Replacement Therapy

Keywords

Intensive care unit; SLEDD-f; intermittent hemodialysis/diafiltration

Outcome Measures

Primary Outcomes (2)

• Fluid overload

  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

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

  day 28

Secondary Outcomes (6)

• Intradialytic hemodynamic tolerance

  during the requiring renal replacement therapy (RRT)

• Mean ultrafiltration rate by patient/ session

  1 day

• Fluid overload

  1 day

• Total duration of RRT

  1 day

• length of stay

  1 day

Study Arms (2)

Low sodium concentration

ACTIVE COMPARATOR

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

Drug: Lowering sodium concentration dialysate

High Sodium Concentration

SHAM COMPARATOR

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

Drug: Highing sodium concentration dialysate

Interventions

Lowering sodium concentration dialysate DRUG

Concentration of sodium in dialysate at 140 mmol/l

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

Low sodium concentration

Highing sodium concentration dialysate DRUG

Concentration of sodium in dialysate at 145 mmol/l

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

High Sodium Concentration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• vincent BRUNOT, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• aurèle BUZANCAIS, MD

  UHNIMES

  STUDY DIRECTOR

Central Study Contacts

vincent BRUNOT, MD

CONTACT

467332495; v-brunot@chu-montpellier.fr

kada KLOUCHE, MD, PhD

CONTACT

467338441; k-klouche@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: simple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: November 1, 2017
• Study Start: April 19, 2018
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): December 19, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (1)