Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate (HEMODIACIDE)

April 3, 2024 updated by: Centre Hospitalier de Bethune

Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate

During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Béthune, France, 62408
        • Recruiting
        • Centre Hospitalier Béthune
        • Contact:
        • Principal Investigator:
          • Martin GÉRARD
        • Sub-Investigator:
          • Christophe VINSONNEAU
      • Caen, France, 14000
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Caen
        • Principal Investigator:
          • Damien DU CHEYRON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient ≥ 18 years old
  • Patient hospitalized in an intensive care unit
  • Patient with acute renal failure defined by a KDIGO stage ≥ 1 and suspected non-obstructive
  • Patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and/or cardiovascular SOFA ≥ 1 and/or lactatemia > 2mmol/L)
  • Indication for Extra Renal Replacement Therapy with IHD.

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Known chronic renal insufficiency of any stage
  • Cardio-renal and hepato renal syndrome
  • Unstable hemodynamic state: refractory shock
  • Patient included in another interventional study likely to modify the hemodynamic state
  • Patient deprived of liberty
  • Patient under guardianship or curatorship
  • Patient not affiliated to a social security system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Using acetate-based dialysate
Device: ACETATE based dialysate
Intermittent hemodialysis with an acetate based dialysate.
Experimental: Experimental group
Using citrate-based dialysate
Device: CITRATE based dialysate
Intermittent hemodialysis with an citrate based dialysate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To show that the use of a citrate-based dialysate decreases the occurrence of intradialytic hypotension in the ICU compared with an acetate-based dialysate (The rate of sessions with occurence of at least one hemodynamic instability (IHI)).
Time Frame: day 28
The rate of sessions with occurence of at least one IHI.
day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;
Time Frame: day 28
Mortality at day 28 and in ICU;
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.
Time Frame: day 28
Length of stay in Intensive Care Unit
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.
Time Frame: day 28
Length of stay in hospital;
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.
Time Frame: day 28
Number of days without dialysis in Intensive Care Unit
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.
Time Frame: day 28
Dialysis dependency at discharge from ICU and hospital.
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h.
Time Frame: day 28
Time to recovery of diuresis > 0.5ml/kg/h
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.
Time Frame: day 28
Change in SOFA score between D0 and D7
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.
Time Frame: day 28
Number of days without catecholamine
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.
Time Frame: day 28
Number of days without mechanical ventilation.
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).
Time Frame: day 28
The ratio of Kt/V (achieved/prescribed)
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).
Time Frame: day 28
Difference between session duration achieved and prescribed
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
Time Frame: day 28
UF ratio (UF prescribed/realized)
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
Time Frame: day 28
Urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates.
Time Frame: day 28
Average, maximum and end-of-session blood and dialysate flow rates.
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.
Time Frame: day 28
The pre-post dialysis variation in creatinine levels
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level.
Time Frame: day 28
The pre-post dialysis variation of pH and bicarbonate level
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.
Time Frame: day 28
The pre-post dialysis variation in kalemia
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium.
Time Frame: day 28
The pre-post dialysis rate variation of sodium, magnesium and calcium
day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.
Time Frame: day 28
The rate of calcium supplemented between two IHD sessions.
day 28
Evaluate the hemodynamic tolerance
Time Frame: Each dialysis until day 28
according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc...
Each dialysis until day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Bethune

Collaborators

CHU de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2023

Primary Completion (Estimated)

January 4, 2025

Study Completion (Estimated)

January 4, 2025

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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