NCT05936710

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2023Jul 2027

First Submitted

Initial submission to the registry

May 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

December 7, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

May 19, 2023

Last Update Submit

January 2, 2026

Conditions

Intradialytic Hypotension

Keywords

citrate based dialysateacetate based dialysatehypotensionhemodynamic tolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • Compare between the two groups (acetate- vs citrate-based dialysate) the 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.

    day 28

  • Compare between the two groups (acetate- vs citrate-based dialysate) the 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.

    day 28

  • Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital.

    day 28

  • +15 more secondary outcomes

Study Arms (2)

Control group

OTHER

Using acetate-based dialysate

Device: ACETATE based dialysate

Experimental group

EXPERIMENTAL

Using citrate-based dialysate

Device: CITRATE based dialysate

Interventions

ACETATE based dialysateDEVICE

Intermittent hemodialysis with an acetate based dialysate.

Control group
CITRATE based dialysateDEVICE

Intermittent hemodialysis with an citrate based dialysate.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Béthune

Béthune, 62408, France

RECRUITING

CHU

Caen, France

RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, France

RECRUITING

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Martin GÉRARD

CONTACT

03.21.64.44.44mgerard@ch-bethune.fr

Christophe VINSONNEAU

CONTACT

03.21.64.44.44cvinsonneau@ch-bethune.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

July 10, 2023

Study Start

December 7, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

FR(4)