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Online Hemodiafiltration vs Conventional Hemodialysis for Acute Kidney Injury (HDFAKI Trial)
N/A
Recruiting
Led By Jean-François Cailhier, MD, PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalised in the ICU
Requiring RRT for AKI, as judged by the attending clinician (initiation) or conversion from CRRT to intermittent dialysis
Must not have
Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
Subjects on active immunosuppressive therapy (>10mg of prednisone, biologic therapies, calcineurin inhibitors, mTOR inhibitors or antimetabolites)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if Online Hemodiafiltration can better reduce inflammation and help kidney recovery in ICU patients with Acute Kidney Injury compared to regular dialysis. The study will check if this new method is feasible for larger trials.
Who is the study for?
This trial is for adults over 18 in the ICU with severe acute kidney injury needing renal replacement therapy, not on chronic dialysis or immunosuppressive drugs, and not pregnant. They must be able to consent and not involved in other dialysis studies.
What is being tested?
The study tests if Online Hemodiafiltration (pre-dilution or post-dilution) can reduce inflammation and improve kidney recovery compared to Conventional Hemodialysis in ICU patients with acute kidney injury.
What are the potential side effects?
Potential side effects may include reactions related to fluid removal like low blood pressure, muscle cramps, nausea; anticoagulation-related issues such as bleeding; and possible infection risks at the vascular access site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently in the intensive care unit.
Select...
I need dialysis for acute kidney injury as decided by my doctor.
Select...
I have severe kidney injury.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, or planning to become pregnant during the study.
Select...
I am currently on strong immunosuppressive medication.
Select...
I cannot take blood thinners during dialysis.
Select...
My kidney function is severely reduced or I am on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to follow-up (feasibility)
Participant accrual (feasibility)
Protocol adherence (feasibility)
Secondary study objectives
Dialysis dependence
End-of-study eGFR
Length of hospitalisation stay
+4 moreOther study objectives
(Exploratory) Inflammatory serum biomarkers modulation
(Exploratory) Phenotype of circulation monocytes
(Exploratory) Phenotype of circulation neutrophils
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Pre-dilution HemodiafiltrationExperimental Treatment1 Intervention
Participants will receive intermittent pre-dilution HDF for a minimum of 4hours per session, 3 to 4 times/week, using the 5008 High-Volume HDF Machine from Fresenius Medical Care with High Flux FX1000 Dialyzer (Mode pre-dilution HDF).
Group II: Post-dilution HemodiafiltrationExperimental Treatment1 Intervention
Participants will receive intermittent post-dilution HDF for a minimum of 4hours per session, 3 to 4 times/week, using the 5008 High-Volume HDF Machine from Fresenius Medical Care with High Flux FX1000 Dialyzer (Mode post-dilution HDF).
Group III: Conventional HemodialysisActive Control1 Intervention
Participants will receive intermittent HD for a minimum of 4hours per session, 3 to 4 times/week, using the 5008 High-Volume HDF Machine from Fresenius Medical Care with High Flux FX1000 Dialyzer (Mode HD).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Kidney Injury (AKI) include conventional intermittent hemodialysis, continuous renal replacement therapy (CRRT), and online hemodiafiltration. These treatments work by removing waste products and excess fluid from the blood, which the damaged kidneys can no longer efficiently filter.
Online hemodiafiltration, in particular, combines diffusion and convection mechanisms to enhance the removal of larger molecules and reduce inflammation, potentially leading to better renal recovery. This is crucial for AKI patients as it helps to stabilize their condition, prevent complications, and support the healing process of the kidneys.
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
380 Previous Clinical Trials
131,544 Total Patients Enrolled
4 Trials studying Acute Kidney Injury
448 Patients Enrolled for Acute Kidney Injury
Jean-François Cailhier, MD, PhDPrincipal InvestigatorCHUM
Jean-Maxime Cote, MD, MScPrincipal InvestigatorCHUM
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently in the intensive care unit.You are already taking part in another study about dialysis treatments.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I am currently on strong immunosuppressive medication.I need dialysis for acute kidney injury as decided by my doctor.I am 18 years old or older.I cannot take blood thinners during dialysis.My kidney function is severely reduced or I am on dialysis.I have severe kidney injury.People who do not want to receive renal replacement therapy (RRT) as part of their life plan.
Research Study Groups:
This trial has the following groups:- Group 1: Post-dilution Hemodiafiltration
- Group 2: Pre-dilution Hemodiafiltration
- Group 3: Conventional Hemodialysis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.