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Recruiting NCT05936710

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

No phase Interventional Intradialytic Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACETATE based dialysate, CITRATE based dialysate.
Who it may be relevant to
Registry conditions: Intradialytic Hypotension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device ACETATE based dialysate
    Intermittent hemodialysis with an acetate based dialysate.
  • Device CITRATE based dialysate
    Intermittent hemodialysis with an citrate based dialysate.

Primary outcome measures

  • 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)). [Time frame: day 28]
Secondary outcome measures (12)
  • Compare between the two groups (acetate- vs citrate-based dialysate) the mortality at day 28 and in ICU; [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the length of stay in Intensive Care Unit. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the Length of stay in hospital. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the Number of days without dialysis in Intensive Care Unit. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the dialysis dependency at discharge from ICU and hospital. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the time to recovery of diuresis > 0.5ml/kg/h. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the change in SOFA score between D0 and D7. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without catecholamine. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the number of days without mechanical ventilation. [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) the ratio of Kt/V (achieved/prescribed). [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) session duration ratio (duration achieved/prescribed). [Time frame: day 28]
  • Compare between the two groups (acetate- vs citrate-based dialysate) UF ratio (UF prescribed/realized) [Time frame: day 28]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 5 centers
  • Centre Hospitalier Béthune — Béthune
  • CHU — Caen
  • Centre Hospitalier Universitaire de Dijon — Dijon
  • CHRU Nancy — Nancy
  • CHU de ROUEN — Rouen

Identifiers

NCT: NCT05936710 · 2023-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗