Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Kidney Injury
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Pilot, Randomised, Open-label, Parallel Groups (co-intervention, 1:1:1) of three interventions: conventional HD, pre-dilution HDF and post-dilution HDFMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 c...
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.
Tracking Information
- NCT #
- NCT04525092
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jean-François Cailhier, MD, PhD CHUM