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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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.
Centre de recherche du CHUM
Montreal, Quebec, Canada
Clinical Research Centre University College Dublin
Dublin, Ireland
Protocol adherence (feasibility)
If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
Time frame: 90 days
Adherence to follow-up (feasibility)
If it was possible to obtain end-of-study outcomes in ≥90% of participants
Time frame: 90 days
Participant accrual (feasibility)
If the average monthly enrolment is 4 or more participants per months
Time frame: 90 days
Mortality
(overall mortality)
Time frame: 30 days
Mortality
(overall mortality)
Time frame: 90 days
End-of-study eGFR
(mL/min/1.73m2)
Time frame: 90 days
Dialysis dependence
Defined as the receipt of dialysis at day 90
Time frame: 90 days
Total number of days on dialysis
(in patients with renal recovery)
Time frame: 90 days
Length of hospitalisation stay
(days)
Time frame: 90 days
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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.
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
Time frame: 7 days
Number of dialysis session complicated by Circuit/filter clotting
(proportion)
Time frame: 90 days