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

NCT ID: NCT05936710

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-07

Study Completion Date

2027-07-31

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.

Detailed Description

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Conditions

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Intradialytic Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

Using acetate-based dialysate

Group Type OTHER

ACETATE based dialysate

Intervention Type DEVICE

Intermittent hemodialysis with an acetate based dialysate.

Experimental group

Using citrate-based dialysate

Group Type EXPERIMENTAL

CITRATE based dialysate

Intervention Type DEVICE

Intermittent hemodialysis with an citrate based dialysate.

Interventions

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ACETATE based dialysate

Intermittent hemodialysis with an acetate based dialysate.

Intervention Type DEVICE

CITRATE based dialysate

Intermittent hemodialysis with an citrate based dialysate.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Lille

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier de Bethune

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Béthune

Béthune, , France

Site Status RECRUITING

CHU

Caen, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, , France

Site Status RECRUITING

CHRU Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Martin GÉRARD

Role: CONTACT

03.21.64.44.44

Christophe VINSONNEAU

Role: CONTACT

03.21.64.44.44

Facility Contacts

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MELANIE VERLAY

Role: primary

0321691028

Other Identifiers

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2023-01

Identifier Type: -

Identifier Source: org_study_id

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