Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury

Last updated: February 14, 2025
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Completed

Phase

N/A

Condition

Renal Failure

Kidney Failure

Kidney Disease

Treatment

Conventional Hemodialysis

Online Post-dilution Hemodiafiltration

Online Pre-dilution Hemodiafiltration

Clinical Study ID

NCT04525092
20.147
  • Ages > 18
  • All Genders

Study Summary

Only limited data exist on the benefit of online hemodiafiltration in patient with Acute kidney injury. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT to determine whether, in patients with AKI requiring acute renal replacement therapy, does exposure to Online Hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the ICU.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hospitalised in the ICU

  • Acute kidney injury stage 3 (KDIGO-AKI Criteria)

  • Requiring RRT for AKI, as judged by the attending clinician (initiation) orconversion from CRRT to intermittent dialysis

  • Adult of 18 years or more

Exclusion

Exclusion Criteria:

  • Female subjects who are pregnant or breast-feeding or considering becoming pregnantduring the study.

  • Subjects who are participating in another study involving dialysis interventions

  • Subjects or relatives/next-of-kin unable to provide written informed consent

  • Creatinine clearance (CrCl) < 30 mL/min measured by 24-hour urine collection or eGFRor on chronic dialysis at baseline

  • Subjects on active immunosuppressive therapy (>10mg of prednisone, biologictherapies, calcineurin inhibitors, mTOR inhibitors or antimetabolites)

  • Subjects with active contraindication to anticoagulation during dialysis session

  • Subjects whose RRT is not part of their life goal

Study Design

Total Participants: 45
Treatment Group(s): 3
Primary Treatment: Conventional Hemodialysis
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
December 01, 2024

Study Description

Despite sparse data on the advantages of hemodiafiltration over conventional hemodialysis for intermittent dialysis, there is limited data comparing these modalities in AKI from various aetiologies in critically ill patients. As RCTs involving renal replacement therapy at the ICU are exceptionally challenging to complete, thus a rigorous RCT based on appropriate sample size and relevant clinical outcomes is crucial. The objective of this pilot RCT is to assess the feasibility of a larger multicentre RCT to determine whether, in patients with AKI requiring acute renal replacement therapy, does exposure to Post-dilution Hemodiafiltration or Pre-dilution Hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the ICU. As post-dilution HDF has never been adequately evaluated in an ICU context, comparison between pre-dilution and post-dilution HDF is also required to confirm feasibility.

This proof-of-concept pilot trial will focus on three feasibility endpoints. It will be considered successful if the following criteria are achieved :

  • Protocol adherence: If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality

  • Adherence to follow-up: If it was possible to obtain end-of-study outcomes in ≥90% of participants, and

  • Participant accrual: If the average monthly enrolment is 4 or more participants per months.

Connect with a study center

  • Centre de recherche du CHUM

    Montreal, Quebec H2X 0C1
    Canada

    Site Not Available

  • Clinical Research Centre University College Dublin

    Dublin,
    Ireland

    Site Not Available

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