Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Device: Conventional Hemodialysis; Device: Online Pre-dilution Hemodiafiltration; Device: Online Post-dilution Hemodiafiltration

• Registration Number: NCT04525092
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

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 Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-25
• Study Start: 2021-01-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Hemodialysis	Conventional Hemodialysis	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).
Pre-dilution Hemodiafiltration	Online Pre-dilution Hemodiafiltration	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).
Post-dilution Hemodiafiltration	Online Post-dilution Hemodiafiltration	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).

Primary Outcome Measures

Name	Time	Method
Participant accrual (feasibility)	90 days	If the average monthly enrolment is 4 or more participants per months
Protocol adherence (feasibility)	90 days	If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
Adherence to follow-up (feasibility)	90 days	If it was possible to obtain end-of-study outcomes in ≥90% of participants

Secondary Outcome Measures

Name	Time	Method
Mortality	90 days	(overall mortality)
Number of dialysis session complicated by Circuit/filter clotting	90 days	(proportion)
Dialysis dependence	90 days	Defined as the receipt of dialysis at day 90
Total number of days on dialysis	90 days	(in patients with renal recovery)
End-of-study eGFR	90 days	(mL/min/1.73m2)
Length of hospitalisation stay	90 days	(days)
Number of patients with hemodynamic instability during dialysis treatment (first week)	7 days	(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

Trial Locations

Locations (2)

Centre de recherche du CHUM; 🇨🇦 Montreal, Quebec, Canada

Clinical Research Centre University College Dublin; 🇮🇪 Dublin, Ireland