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Studies

Interventional Recruiting

NCT05936710 on ClinicalTrials.gov

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

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

  • Sponsor: Centre hospitalier
  • Collaborators: CHU de Lille
  • Enrollment: 48 (Estimated)
  • Study start: 2023-12-07 (Actual)
  • Primary completion: 2027-07-01 (Estimated)
  • Study completion: 2027-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Intradialytic Hypotension

Intervention / Treatment

  • Device: ACETATE based dialysate
  • Device: 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)). (day 28)
    The rate of sessions with occurence of at least one IHI.

Countries

France

Locations and Investigators

  • Centre Hospitalier Béthune, Béthune, France (Recruiting)
    • MELANIE VERLAY
    • Martin GÉRARD (Principal Investigator)
    • Christophe VINSONNEAU
  • CHU, Caen, France (Recruiting)
    • Damien DU CHEYRON, Professor (Principal Investigator)
  • Centre Hospitalier Universitaire de Dijon, Dijon, France (Recruiting)
    • Jean-Pierre QUENOT (Principal Investigator)
  • CHRU Nancy, Nancy, France (Recruiting)
    • Sébastien GIBOT, Professor (Principal Investigator)
  • CHU de ROUEN, Rouen, France (Not yet recruiting)