Clinical trial NCT05936710: Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
Official title: Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intradialytic Hypotension
Keywords: citrate based dialysate
acetate based dialysate
hypotension
hemodynamic tolerance
Lead sponsor: Centre Hospitalier de Bethune
Sponsor class: NETWORK
Collaborators: name: CHU de Lille
First posted: 2023-07-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
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)).
timeFrame: day 28
Secondary outcomes:
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium.
timeFrame: day 28
measure: Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.
timeFrame: day 28
measure: Evaluate the hemodynamic tolerance
timeFrame: Each dialysis until day 28
Other outcomes:
Locations:
city: Béthune
country: France
facility: Centre Hospitalier Béthune
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
Study officials:
References: