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RecruitingNCT05936710HEMODIACIDEUpdated May 8, 2026

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

An interventional study of ACETATE based dialysate and CITRATE based dialysate in Intradialytic Hypotension, sponsored by Centre Hospitalier de Bethune. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Centre Hospitalier de Bethune · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Intradialytic Hypotension

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Keywords

  • citrate based dialysate
  • acetate based dialysate
  • hypotension
  • hemodynamic tolerance
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 48 is below the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Centre Hospitalier de Bethune is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Other
    Control group

    Using acetate-based dialysate

    Device: ACETATE based dialysate

  • Experimental
    Experimental group

    Using citrate-based dialysate

    Device: CITRATE based dialysate

Interventions

  • DeviceACETATE based dialysate

    Intermittent hemodialysis with an acetate based dialysate.

  • DeviceCITRATE based dialysate

    Intermittent hemodialysis with an citrate based dialysate.

06

What researchers measure

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.

    Time frame: day 28

Secondary outcomes

  1. Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU;

    Mortality at day 28 and in ICU;

    Time frame: day 28

  2. Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit.

    Length of stay in Intensive Care Unit

    Time frame: day 28

  3. Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital.

    Length of stay in hospital;

    Time frame: day 28

  4. Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit.

    Number of days without dialysis in Intensive Care Unit

    Time frame: day 28

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

    Dialysis dependency at discharge from ICU and hospital.

    Time frame: day 28

  6. Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h.

    Time to recovery of diuresis \> 0.5ml/kg/h

    Time frame: day 28

  7. Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7.

    Change in SOFA score between D0 and D7

    Time frame: day 28

  8. Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine.

    Number of days without catecholamine

    Time frame: day 28

  9. Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation.

    Number of days without mechanical ventilation.

    Time frame: day 28

  10. Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed).

    The ratio of Kt/V (achieved/prescribed)

    Time frame: day 28

  11. Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed).

    Difference between session duration achieved and prescribed

    Time frame: day 28

  12. Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized)

    UF ratio (UF prescribed/realized)

    Time frame: day 28

  13. Compare between the two groups (acetate- vs citrate-based dialysate) urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)

    Urea reduction rate (pre-dialysis urea - post-dialysis urea/pre-dialysis urea)

    Time frame: day 28

  14. Compare between the two groups (acetate- vs citrate-based dialysate) average, maximum and end-of-session blood and dialysate flow rates.

    Average, maximum and end-of-session blood and dialysate flow rates.

    Time frame: day 28

  15. Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in creatinine levels.

    The pre-post dialysis variation in creatinine levels

    Time frame: day 28

  16. Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation of pH and bicarbonate level.

    The pre-post dialysis variation of pH and bicarbonate level

    Time frame: day 28

  17. Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis variation in kalemia.

    The pre-post dialysis variation in kalemia

    Time frame: day 28

  18. Compare between the two groups (acetate- vs citrate-based dialysate) the pre-post dialysis the rate variation of sodium, magnesium and calcium.

    The pre-post dialysis rate variation of sodium, magnesium and calcium

    Time frame: day 28

  19. Compare between the two groups (acetate- vs citrate-based dialysate) the rate of calcium supplemented between two IHD sessions.

    The rate of calcium supplemented between two IHD sessions.

    Time frame: day 28

  20. Evaluate the hemodynamic tolerance

    according to the randomization groups : the response to the passive leg raising, respiratory variation of the inferior vena cava etc...

    Time frame: Each dialysis until day 28

07

Study locations

4 of 5 sites recruiting
  • Centre Hospitalier Béthune
    Béthune, 62408, France
    • MELANIE VERLAY · Contact · mverlay@ch-lens.fr · 0321691028
    • Martin GÉRARD · Principal investigator
    • Christophe VINSONNEAU · Sub investigator
    Recruiting
  • CHU
    Caen, France
    • Damien DU CHEYRON, Professor · Principal investigator
    Recruiting
  • Centre Hospitalier Universitaire de Dijon
    Dijon, France
    • Jean-Pierre QUENOT · Principal investigator
    Recruiting
  • CHRU Nancy
    Nancy, France
    • Sébastien GIBOT, Professor · Principal investigator
    Recruiting
  • CHU de ROUEN
    Rouen, 59507, France
    • Jonathan NICOLAS, MD · Principal investigator
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05936710
Lead sponsor
Centre Hospitalier de Bethune
Collaborators
CHU de Lille
Responsible party
Sponsor
First posted
Jul 10, 2023
Start date
Dec 7, 2023
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
May 8, 2026

Study contacts

Martin GÉRARD
Contact
mgerard@ch-bethune.fr
03.21.64.44.44
Christophe VINSONNEAU
Contact
cvinsonneau@ch-bethune.fr
03.21.64.44.44

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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