HOME AKI, Haemofiltration with Oxiris: Multicentre Evaluation in Acute Kidney Injury is a pilot randomised study in Victoria, Australia.
Acute kidney injury (AKI) is a common problem and when severe results in the need for renal replacement therapy (RRT). Sepsis and other inflammatory syndromes commonly result in AKI requiring RRT in intensive care and this is associated with high patient mortality. Failure of the RRT circuit leads to lack of treatment time, blood loss and increased costs (both financial and care giver time).
Advances in technology provide an opportunity to assess new membranes in RRT for both patient and circuit outcomes. The oXiris membrane is a recent development in haemofilter membrane technology that advances on the AN69ST membrane currently in use. It is treated to allow increased adsorption of endotoxin (produced by bacteria and contributing to the sepsis process) and cytokines associated with septic shock. Additionally, the membrane is heparin-bonded which may reduce the risk of circuit failure and have an effect on the inflammatory response without exposing the patient to bleeding risk.
The potential for a membrane to reduce the inflammatory response and therefore reduce vasopressor requirements in septic shock is clinically appealing. To date there have been limited published human trials of the oXiris membrane, although case control studies have suggested a reduction in organ failure scores and potentially s longer useful time of circuit function. European groups have had positive experiences with the membrane, and it has been successfully implemented in ICUs in Victoria as it has Australian Therapeutic Goods approval for clinical use, however there is limited clinical trial data available. The oXiris membrane is easily integrated with existing clinical care and this multicentre randomised controlled trial will identify if it has a physiological effect on the shock state or requirement of vasoactive support, as well as any impact on treatment adequacy (by increasing circuit life). Additionally, there is the prospect of new information about possible effects on the proteins and metabolites produced in septic shock during RRT, providing an opportunity for detection of future biomarkers or treatment targets.
Short title: HOME-AKI
Summary
A pilot multicentre open-label randomised controlled trial during treatment for acute kidney injury in critically ill patients with septic shock comparing two haemofilter membrane devices, both of which are approved on the Australian Register of Therapeutics Goods (ARTG).
The research control is the current standard AN69ST (acryl nitrite 69 surface treated, ARTG ID 195199) haemofiltration membrane which will be compared with the newly available oXiris haemofiltration membrane (ARTG ID 302001) for clinical and technical filter performance outcomes.
Design
Prospective, multicentre, parallel group, open-label, randomised controlled trial
Outcomes
Primary
Time alive and vasopressor free at 7 days (hours)
Secondary
Median circuit life (hours)
Mortality at 7, 28 and 90 days
Vasopressor requirements – cumulatively during entire treatment; and at 4 hours, 12 hours and 24 hours
Cumulative fluid requirements at 4 hours, 12 hours and 24 hours
Change in SOFA score at 24 and 48 hours
Duration of requirement of renal replacement therapy
Renal replacement therapy requirement at 28 and 90 days
Change in inflammatory markers during first 7 days of treatment where measured (white cells, C-reactive protein)
Analysis of circuit haemodynamic profiles
Tertiary
Patient cytokine levels (IL-6, IL-8, IL-10, TNF-α) at time 0, 4-6 and 24 hours within a subgroup of patients
Patient blood beta lactam antibiotic levels at time 0, 4 and 24 hours within a subgroup of patients
Patient blood and effluent metabolomic and blood proteomic profiles at time 0, 4-6 and 20-24 hours within a subgroup of patients
Intervention
AN69ST or oXiris membrane for all CRRT in ICU patients with septic shock and acute kidney injury from the first episode of CRRT until ICU discharge
Sample size
150 patients
Eligibility criteria
Inclusion Criteria (must have 1 + 2 +3)
Exclusion Criteria (any)
