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

May 5, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Béthune, France, 62408
        • Recruiting
        • Centre Hospitalier Béthune
        • Contact:
        • Principal Investigator:
          • Martin GÉRARD
        • Sub-Investigator:
          • Christophe VINSONNEAU
      • Caen, France
        • Recruiting
        • CHU
        • Principal Investigator:
          • Damien DU CHEYRON, Professor
      • Dijon, France
        • Recruiting
        • Centre Hospitalier Universitaire De Dijon
        • Principal Investigator:
          • Jean-Pierre QUENOT
      • Nancy, France
        • Recruiting
        • CHRU Nancy
        • Principal Investigator:
          • Sébastien GIBOT, Professor
      • Rouen, France, 59507
        • Not yet recruiting
        • CHU de ROUEN
        • Principal Investigator:
          • Jonathan NICOLAS, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier de Bethune

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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