ACETATE based dialysate
DeviceIntermittent hemodialysis with an acetate based dialysate.
Recruiting
NCT Number: NCT05936710
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite 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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Centre Hospitalier Béthune, Béthune, France
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
CITRATE based dialysate
DeviceIntermittent hemodialysis with an citrate based dialysate.
Primary outcomes
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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.
Secondary outcomes
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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;
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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
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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;
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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
-
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.
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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
-
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
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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
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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.
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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)
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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
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Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
Time frame: day 28
UF ratio (UF prescribed/realized)
-
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)
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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.
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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
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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
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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
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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
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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.
-
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...
Study contacts
Contact information is provided by the study sponsor or research team.
Christophe VINSONNEAU
CONTACT
Martin GÉRARD
CONTACT
Sponsors and collaborators
Lead sponsor
Centre Hospitalier de Bethune
Network
Collaborators
- CHU de Lille
Registry information
Official study title
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate
Acronym: HEMODIACIDE
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 10, 2023
- Registry last updated
- May 8, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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