Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury
HDFAKI
Evaluation of the Impact of Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury on Inflammatory and Clinical Outcomes
1 other identifier
interventional
45
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 18, 2025
February 1, 2025
3.9 years
August 17, 2020
February 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Protocol adherence (feasibility)
If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
90 days
Adherence to follow-up (feasibility)
If it was possible to obtain end-of-study outcomes in ≥90% of participants
90 days
Participant accrual (feasibility)
If the average monthly enrolment is 4 or more participants per months
90 days
Secondary Outcomes (8)
Mortality
30 days
Mortality
90 days
End-of-study eGFR
90 days
Dialysis dependence
90 days
Total number of days on dialysis
90 days
- +3 more secondary outcomes
Other Outcomes (3)
(Exploratory) Inflammatory serum biomarkers modulation
Day 0 and Day 7
(Exploratory) Phenotype of circulation neutrophils
Day 0 and Day 7
(Exploratory) Phenotype of circulation monocytes
Day 0 and Day 7
Study Arms (3)
Conventional Hemodialysis
ACTIVE COMPARATORParticipants 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).
Pre-dilution Hemodiafiltration
EXPERIMENTALParticipants 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).
Post-dilution Hemodiafiltration
EXPERIMENTALParticipants 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).
Interventions
The following parameters: maximum Blood flow rate allowed by vascular access, dialyste rate of 500 mL/min and average convective volume of \>44L/session reinjected in pre-dilution mode. The dialysate composition, net ultrafiltration rate and use of anticoagulation will be prescribed according to participant's characteristics.
Using the following parameters: maximum Blood flow rate allowed by vascular access, dialysate rate of 500 mL/min, no convection. The dialysate composition, net ultrafiltration rate and use of anticoagulation will be prescribed according to participant's characteristics.
The following parameters: maximum Blood flow rate allowed by vascular access, dialyste rate of 500 mL/min and average convective volume of \>22L/session reinjected in pre-dilution mode. The dialysate composition and net ultrafiltration rate will be prescribed according to participant's characteristics. Usage of intra-dialysis anticoagulation is mandatory.
Eligibility Criteria
You may qualify if:
- Hospitalised in the ICU
- Acute kidney injury stage 3 (KDIGO-AKI Criteria)
- Requiring RRT for AKI, as judged by the attending clinician (initiation) or conversion from CRRT to intermittent dialysis
- Adult of 18 years or more
You may not qualify if:
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during 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 eGFR or on chronic dialysis at baseline
- Subjects on active immunosuppressive therapy (\>10mg of prednisone, biologic therapies, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre de recherche du CHUM
Montreal, Quebec, H2X 0C1, Canada
Clinical Research Centre University College Dublin
Dublin, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Maxime Cote, MD, MSc
CHUM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 25, 2020
Study Start
January 1, 2021
Primary Completion
November 30, 2024
Study Completion
December 1, 2024
Last Updated
February 18, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share