Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04525092
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact	Jean Maxime Cote, MD, MSc
Phone	514 890 8000
Email	jean-maxime.cote@umontreal.ca
Status	Recruiting
Phase	N/A
Start date	January 1, 2021
Completion date	March 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury — HDFAKI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms