Intradialytic HypotensionHEMODIACIDENCT05936710
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
A study testing ACETATE based dialysate and CITRATE based dialysate in people with Intradialytic Hypotension, run by Centre Hospitalier de Bethune at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension
- What is being tested?
- ACETATE based dialysate and CITRATE based dialysate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Dec 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre Hospitalier Béthune
Béthune, 62408
MELANIE VERLAY, 0321691028, mverlay@ch-lens.fr
Martin GÉRARD
- Recruiting
CHU
Caen
Damien DU CHEYRON, Professor
- Recruiting
Centre Hospitalier Universitaire de Dijon
Dijon
Jean-Pierre QUENOT
- Recruiting
CHRU Nancy
Nancy
Sébastien GIBOT, Professor
- Not yet recruiting
CHU de ROUEN
Rouen, 59507
Jonathan NICOLAS, MD
About this study
Official title: 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.
- Conditions
- Intradialytic Hypotension
- Being tested
- ACETATE based dialysate, CITRATE based dialysate
- Keywords
- citrate based dialysate, acetate based dialysate, hypotension, hemodynamic tolerance
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACETATE based dialysateDevice
Intermittent hemodialysis with an acetate based dialysate.
CITRATE based dialysateDevice
Intermittent hemodialysis with an citrate based dialysate.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Using acetate-based dialysate Receives: Device: ACETATE based dialysate |
| Experimental group | Experimental | Using citrate-based dialysate Receives: Device: CITRATE based dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
The rate of sessions with occurence of at least one IHI.
Measured: day 28
Secondary outcomes (20)
Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;
Mortality at day 28 and in ICU;
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.
Length of stay in Intensive Care Unit
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.
Length of stay in hospital;
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.
Number of days without dialysis in Intensive Care Unit
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.
Dialysis dependency at discharge from ICU and hospital.
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h.
Time to recovery of diuresis > 0.5ml/kg/h
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.
Change in SOFA score between D0 and D7
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.
Number of days without catecholamine
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.
Number of days without mechanical ventilation.
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).
The ratio of Kt/V (achieved/prescribed)
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).
Difference between session duration achieved and prescribed
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
UF ratio (UF prescribed/realized)
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
Urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates.
Average, maximum and end-of-session blood and dialysate flow rates.
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.
The pre-post dialysis variation in creatinine levels
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level.
The pre-post dialysis variation of pH and bicarbonate level
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.
The pre-post dialysis variation in kalemia
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium.
The pre-post dialysis rate variation of sodium, magnesium and calcium
Measured: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.
The rate of calcium supplemented between two IHD sessions.
Measured: day 28
Evaluate the hemodynamic tolerance
according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc...
Measured: Each dialysis until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start7 Dec 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bethune
- Sponsor type
- Research network
- Collaborators
- CHU de Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936710
- Sponsor's protocol ID
- 2023-01
- Acronym
- HEMODIACIDE
- Status last verified
- May 2026
- First submitted
- 19 May 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate
- ClinicalTrials.gov ID
- NCT05936710
- Acronym / sponsor ID
- HEMODIACIDE / 2023-01
- Conditions
- Intradialytic Hypotension
- Keywords
- citrate based dialysate, acetate based dialysate, hypotension, hemodynamic tolerance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier de BethuneResearch network
- Collaborators
- CHU de Lille
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: ACETATE based dialysateUsing acetate-based dialysate |
| Experimental group | Experimental | Device: CITRATE based dialysateUsing citrate-based dialysate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACETATE based dialysateIntermittent hemodialysis with an acetate based dialysate. | Device | Control group |
| CITRATE based dialysateIntermittent hemodialysis with an citrate based dialysate. | Device | Experimental group |
Primary outcome
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.
20 secondary outcomes
Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.
Time frame: 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
Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.
Time frame: 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
Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).
Time frame: day 28
Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
Time frame: 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
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
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.
Time frame: 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
Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.
Time frame: 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
Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.
Time frame: day 28
Evaluate the hemodynamic tolerance
Time frame: Each dialysis until day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACETATE based dialysate and CITRATE based dialysate in people with Intradialytic Hypotension, run by Centre Hospitalier de Bethune at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin GÉRARD (03.21.64.44.44, mgerard@ch-bethune.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.