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Clinical Trials in France / NCT05936710
Recruiting Not applicable

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

NCT05936710 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier de Bethune
Phase
Not applicable
Started
2023-12-07
Last updated
2026-05-08

Condition(s) studied

Intradialytic Hypotension

Investigational drug(s) / intervention(s)

ACETATE based dialysateCITRATE based dialysate

ACETATE based dialysate: Intermittent hemodialysis with an acetate based dialysate.

CITRATE based dialysate: Intermittent hemodialysis with an citrate based dialysate.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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)). — day 28
    The rate of sessions with occurence of at least one IHI.

Trial sites (5)

FacilityCityRegionStatus
Centre Hospitalier Béthune Béthune France Recruiting
CHU Caen France Recruiting
Centre Hospitalier Universitaire de Dijon Dijon France Recruiting
CHRU Nancy Nancy France Recruiting
CHU de ROUEN Rouen France Not Yet Recruiting

More Centre Hospitalier de Bethune trials in France

Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock. Recruiting
Diaphragm Response in Elderly for Acute Monitoring Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05936710 on ClinicalTrials.gov ↗ ← All trials in France