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

C

Centre Hospitalier de Bethune

Status

Enrolling

Conditions

Intradialytic Hypotension

Treatments

Device: ACETATE based dialysate
Device: CITRATE based dialysate

Study type

Interventional

Funder types

NETWORK
Other

Identifiers

NCT05936710
2023-01

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

Control group
Other group
Description:
Using acetate-based dialysate
Treatment:
Device: ACETATE based dialysate
Experimental group
Experimental group
Description:
Using citrate-based dialysate
Treatment:
Device: CITRATE based dialysate

Trial contacts and locations

4

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Central trial contact

Christophe VINSONNEAU; Martin GÉRARD

Data sourced from clinicaltrials.gov

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