NCT05936710 Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate
| NCT ID | NCT05936710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier de Bethune |
| Condition | Intradialytic Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-12-07 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2023-12-07 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05936710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intradialytic Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05936710 currently recruiting?
Yes, NCT05936710 is actively recruiting participants. Contact the research team at mgerard@ch-bethune.fr for enrollment information.
Where is the NCT05936710 trial being conducted?
This trial is being conducted at Béthune, France, Caen, France, Dijon, France, Nancy, France and 1 additional location.
Who is sponsoring the NCT05936710 clinical trial?
NCT05936710 is sponsored by Centre Hospitalier de Bethune. The trial plans to enroll 48 participants.