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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
HDFAKI Trial Summary
This trial is testing whether a new kind of dialysis, called Online Hemodiafiltration, reduces inflammation and improves kidney recovery in patients with Acute Kidney Injury.
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.Check my eligibility
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.See study design
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.
HDFAKI Trial 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.
HDFAKI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to follow-up (feasibility)
Participant accrual (feasibility)
Protocol adherence (feasibility)
Secondary outcome measures
Dialysis dependence
End-of-study eGFR
Length of hospitalisation stay
+4 moreOther outcome measures
(Exploratory) Inflammatory serum biomarkers modulation
(Exploratory) Phenotype of circulation monocytes
(Exploratory) Phenotype of circulation neutrophils
HDFAKI 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).
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,592 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
350 Patients Enrolled for Acute Kidney Injury
Jean-François Cailhier, MD, PhDPrincipal InvestigatorCHUM
Jean-Maxime Cote, MD, MScPrincipal InvestigatorCHUM
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What particular goals is this research endeavor attempting to accomplish?
"This clinical trial, lasting around 90 days, is mainly focused on evaluating the feasibility of patient adherence. Secondary metrics include hospital stay duration (measured in days), number of patients affected by hemodynamic instability during dialysis treatment (first week via two definitions: systolic blood pressure drop <90 mmHg requiring intervention and variations in vasoactive-inotropic score between pre-dialysis and post-dialysis timepoints), as well as assessing degree of dialysis dependence at day 90."
Answered by AI
How many people are participating in this medical trial?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this clinical trial is actively searching for participants, with the initial posting dating back to January 1st 2021 and the most recent revisions made October 11th 2022. 45 potential candidates are needed across a single medical centre."
Answered by AI
Is enrollment in this research endeavor still accessible to participants?
"Yes, the clinicaltrials.gov website states that this trial is still in search of participants. Originally posted on January 1st 2021, it was last updated on October 11th 2022 and seeks 45 people from a single site."
Answered by AI
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