Effects of Variation of Sodium Dialysate in ICU (NADIRA)

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: Recruiting
• Conditions: Acute Kidney Injury; Renal Replacement Therapy
• Intervention / Treatment: Drug: Lowering sodium concentration dialysate; Drug: Highing sodium concentration 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 Type: Interventional
• Enrollment (Estimated): 158
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: vincent BRUNOT, MD; Phone Number: 33 467332495; Email: v-brunot@chu-montpellier.fr
• Study Contact Backup: Name: kada KLOUCHE, MD, PhD; Phone Number: 33 467338441; Email: k-klouche@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UHMontpellier
    • Contact: vincent BRUNOT, MD; Phone Number: 33 467332495; Email: v-brunot@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intradialytic hemodynamic tolerance	Intradialytic hemodynamic tolerance	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	1 day
Fluid overload	Fluid overload after RRT weaning and ICU stay.	1 day
Total duration of RRT	Total duration of RRT at end of hospitalization	1 day
length of stay	Length of stay in the service at hospital discharge	1 day
Mortality rate	Mortality rate at 28 days of admission	28 days of admission

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: vincent BRUNOT, MD, University Hospital, Montpellier; Study Director: aurèle BUZANCAIS, MD, UHNIMES

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intensive care unit; SLEDD-f; intermittent hemodialysis/diafiltration
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: UF9744

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