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Effects of Variation of Sodium Dialysate in ICU (NADIRA)

Primary Purpose

Acute Kidney Injury, Renal Replacement Therapy

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Lowering sodium concentration dialysate
Highing sodium concentration dialysate
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Intensive care unit, SLEDD-f, intermittent hemodialysis/diafiltration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UhmontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low sodium concentration

High Sodium Concentration

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fluid overload
Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.
Fluid overload
Daily weight measure from the initiation to the weaning of RRT.

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2017
Last Updated
September 16, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03329313
Brief Title
Effects of Variation of Sodium Dialysate in ICU
Acronym
NADIRA
Official Title
Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Renal Replacement Therapy
Keywords
Intensive care unit, SLEDD-f, intermittent hemodialysis/diafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
simple blind
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low sodium concentration
Arm Type
Active Comparator
Arm Description
Concentration of sodium in dialysate at 140 mmol/l ( Lowering sodium concentration dialysate)
Arm Title
High Sodium Concentration
Arm Type
Sham Comparator
Arm Description
Concentration of sodium in dialysate at 145 mmol/l (Highing sodium concentration dialysate)
Intervention Type
Drug
Intervention Name(s)
Lowering sodium concentration dialysate
Other Intervention Name(s)
Concentration of sodium in dialysate at 140 mmol/l
Intervention Description
Concentration of sodium in dialysate at 140 mmol/l
Intervention Type
Drug
Intervention Name(s)
Highing sodium concentration dialysate
Other Intervention Name(s)
Concentration of sodium in dialysate at 145 mmol/l
Intervention Description
Concentration of sodium in dialysate at 145 mmol/l
Primary Outcome Measure Information:
Title
Fluid overload
Description
Daily weight measure from the initiation to the weaning of RRT. Daily monitoring of inpout and output.
Time Frame
7 days after the initiation of renal replacement therapy
Title
Fluid overload
Description
Daily weight measure from the initiation to the weaning of RRT.
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Intradialytic hemodynamic tolerance
Description
Intradialytic hemodynamic tolerance
Time Frame
during the requiring renal replacement therapy (RRT)
Title
Mean ultrafiltration rate by patient/ session
Description
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
Time Frame
1 day
Title
Fluid overload
Description
Fluid overload after RRT weaning and ICU stay.
Time Frame
1 day
Title
Total duration of RRT
Description
Total duration of RRT at end of hospitalization
Time Frame
1 day
Title
length of stay
Description
Length of stay in the service at hospital discharge
Time Frame
1 day
Title
Mortality rate
Description
Mortality rate at 28 days of admission
Time Frame
28 days of admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
vincent BRUNOT, MD
Phone
467332495
Ext
33
Email
v-brunot@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
kada KLOUCHE, MD, PhD
Phone
467338441
Ext
33
Email
k-klouche@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
vincent BRUNOT, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
aurèle BUZANCAIS, MD
Organizational Affiliation
UHNIMES
Official's Role
Study Director
Facility Information:
Facility Name
Uhmontpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
vincent BRUNOT, MD
Phone
467332495
Ext
33
Email
v-brunot@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
NC

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Effects of Variation of Sodium Dialysate in ICU

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