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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intradialytic Hypotension

Intervention / Treatment
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* Device: ACETATE based dialysate
* Device: CITRATE based dialysate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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)). | 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; | 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. | 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. | 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. | 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. | 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 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. | 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. | Number of days without catecholamine | 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. | 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) | 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 | day 28 | 
| Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized) | 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) | 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. | 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. | 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. | 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. | 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. | 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. | The rate of calcium supplemented between two IHD sessions. | 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... | Each dialysis until day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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citrate based dialysate, acetate based dialysate, hypotension, hemodynamic tolerance