Acute Kidney InjuryHDFAKINCT04525092
Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury
A study testing Online Pre-dilution Hemodiafiltration, Conventional Hemodialysis and Online Post-dilution Hemodiafiltration in people with Acute Kidney Injury, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Online Pre-dilution Hemodiafiltration, Conventional Hemodialysis and Online Post-dilution Hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the Impact of Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury on Inflammatory and Clinical Outcomes
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.
Read the detailed 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Online Pre-dilution Hemodiafiltration, Conventional Hemodialysis, Online Post-dilution Hemodiafiltration
- Keywords
- hemodialysis, hemodiafiltration, Acute kidney injury, AKI, Renal replacement therapy, Inflammation
- Medical subject headings
- Acute Kidney Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Pre-dilution HemodiafiltrationDevice
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.
Conventional HemodialysisDevice
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.
Online Post-dilution HemodiafiltrationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Hemodialysis | Active comparator | 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). Receives: Device: Conventional Hemodialysis |
| Pre-dilution Hemodiafiltration | Experimental | 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). Receives: Device: Online Pre-dilution Hemodiafiltration |
| Post-dilution Hemodiafiltration | Experimental | 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). Receives: Device: Online Post-dilution Hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol adherence (feasibility)
If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
Measured: 90 days
Adherence to follow-up (feasibility)
If it was possible to obtain end-of-study outcomes in ≥90% of participants
Measured: 90 days
Participant accrual (feasibility)
If the average monthly enrolment is 4 or more participants per months
Measured: 90 days
Secondary outcomes (8)
Mortality
(overall mortality)
Measured: 30 days
Mortality
(overall mortality)
Measured: 90 days
End-of-study eGFR
(mL/min/1.73m2)
Measured: 90 days
Dialysis dependence
Defined as the receipt of dialysis at day 90
Measured: 90 days
Total number of days on dialysis
(in patients with renal recovery)
Measured: 90 days
Length of hospitalisation stay
(days)
Measured: 90 days
Number of patients with hemodynamic instability during dialysis treatment (first week)
(using two definitions):
- Defined as systolic blood pressure drop <90 mmHg requiring intervention (one of the following: increase of vasopressor, Ultrafiltration cessation/reduction, termination of the dialysis session or fluid bolus)
- Variations in the vasoactive-inotropic score between pre-dialysis and per-dialysis timepoint
Measured: 7 days
Number of dialysis session complicated by Circuit/filter clotting
(proportion)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jan 2021
- Primary completion30 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, Randomised, Open-label, Parallel Groups (co-intervention, 1:1:1) of three interventions: conventional HD, pre-dilution HDF and post-dilution HDF
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Maxime Cote, MD, MSc, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525092
- Sponsor's protocol ID
- 20.147
- Acronym
- HDFAKI
- Status last verified
- Feb 2025
- First submitted
- 17 Aug 2020
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury on Inflammatory and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04525092
- Acronym / sponsor ID
- HDFAKI / 20.147
- Conditions
- Acute Kidney Injury
- Keywords
- hemodialysis, hemodiafiltration, Acute kidney injury, AKI, Renal replacement therapy, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pilot, Randomised, Open-label, Parallel Groups (co-intervention, 1:1:1) of three interventions: conventional HD, pre-dilution HDF and post-dilution HDF
| Arm | Type | Receives |
|---|---|---|
| Conventional Hemodialysis | Active comparator | Device: Conventional HemodialysisParticipants 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 | Experimental | Device: Online Pre-dilution HemodiafiltrationParticipants 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 | Experimental | Device: Online Post-dilution HemodiafiltrationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Pre-dilution HemodiafiltrationThe 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. | Device | Pre-dilution Hemodiafiltration |
| Conventional HemodialysisUsing 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. | Device | Conventional Hemodialysis |
| Online Post-dilution HemodiafiltrationThe 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. | Device | Post-dilution Hemodiafiltration |
Primary outcome
Protocol adherence (feasibility)
Time frame: 90 days
If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
Adherence to follow-up (feasibility)
Time frame: 90 days
If it was possible to obtain end-of-study outcomes in ≥90% of participants
Participant accrual (feasibility)
Time frame: 90 days
If the average monthly enrolment is 4 or more participants per months
8 secondary outcomes
Mortality
Time frame: 30 days
Mortality
Time frame: 90 days
End-of-study eGFR
Time frame: 90 days
Dialysis dependence
Time frame: 90 days
Total number of days on dialysis
Time frame: 90 days
Length of hospitalisation stay
Time frame: 90 days
Number of patients with hemodynamic instability during dialysis treatment (first week)
Time frame: 7 days
Number of dialysis session complicated by Circuit/filter clotting
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Maxime Cote, MD, MSc principal investigator
CHUM
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Pre-dilution Hemodiafiltration, Conventional Hemodialysis and Online Post-dilution Hemodiafiltration in people with Acute Kidney Injury, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol adherence (feasibility) (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.