Clinical trial NCT04525092: Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury
Official title: Evaluation of the Impact of Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury on Inflammatory and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: hemodialysis
hemodiafiltration
Acute kidney injury
AKI
Renal replacement therapy
Inflammation
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Protocol adherence (feasibility)
timeFrame: 90 days
measure: Adherence to follow-up (feasibility)
timeFrame: 90 days
measure: Participant accrual (feasibility)
timeFrame: 90 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 90 days
measure: End-of-study eGFR
timeFrame: 90 days
measure: Dialysis dependence
timeFrame: 90 days
measure: Total number of days on dialysis
timeFrame: 90 days
measure: Length of hospitalisation stay
timeFrame: 90 days
measure: Number of patients with hemodynamic instability during dialysis treatment (first week)
timeFrame: 7 days
measure: Number of dialysis session complicated by Circuit/filter clotting
timeFrame: 90 days
Other outcomes:
measure: (Exploratory) Inflammatory serum biomarkers modulation
timeFrame: Day 0 and Day 7
measure: (Exploratory) Phenotype of circulation neutrophils
timeFrame: Day 0 and Day 7
measure: (Exploratory) Phenotype of circulation monocytes
timeFrame: Day 0 and Day 7
Locations:
city: Montreal
country: Canada
facility: Centre de recherche du CHUM
state: Quebec
city: Dublin
country: Ireland
facility: Clinical Research Centre University College Dublin
Study officials:
affiliation: CHUM
name: Jean-Maxime Cote, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: