Not Yet RecruitingPhase 4ACTRN12620000514909

Haemofiltration with OXiris: Multicentre Evaluation in Acute Kidney Injury (HOME-AKI). A pilot study comparing two devices used for renal replacement therapy in the intensive care unit in patients with acute kidney injury related to sepsis.

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, the AN69ST and the newly available oXiris haemofiltration membrane for early resolution of shock as well as other clinical and technical performance outcomes.


Sponsor

Melbourne Health

Enrollment

150 participants

Start Date

Jun 1, 2020

Study Type

Interventional

Conditions

Summary

Sepsis and other inflammatory syndromes commonly result in acute kidney Injury requiring renal replacement therapy (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). The oXiris membrane is a recent development in haemofilter membrane technology that advances on the 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 and the membrane is heparin-bonded which may reduce the risk of circuit failure. 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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria11

  • Sepsis, as defined by:
  • 1. Suspected or documented infection AND
  • 2. An acute increase of greater than 2 SOFA points consequent to the infection (indicating organ dysfunction)
  • Septic shock, as defined by:
  • 1. Sepsis and need for vasopressor therapy to keep mean arterial pressure (MAP) greater than or equal to 65 mmHg for greater than or equal to 2 hours
  • 2. Lactate greater than 2 mmol/L after volume resuscitation at any time in the preceding 24 hours
  • Acute kidney injury with the requirement for CRRT to control one or more of:
  • 1. Volume status/fluid overload
  • 2. Hyperkalaemia
  • 3. Metabolic acidosis
  • 4. Uraemia

Exclusion Criteria6

  • Known chronic kidney disease stage 5 (eGFR < 15 mL/min/1.73m2) or on established renal replacement therapy (peritoneal or intermittent haemodialysis)
  • Previous renal replacement therapy on this hospital admission
  • Known heparin sensitivity (e.g. heparin induced thrombocytopaenia, HIT)
  • Anticipated concurrent use of extracorporeal membrane oxygenation (ECMO)
  • Age <18 years
  • Pregnancy

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Interventions

The intervention is continuous renal replacement (CRRT) with the newly available oXiris haemofiltration membrane (ARTG ID 302001). The intervention is an approved device which is used in place of anot

The intervention is continuous renal replacement (CRRT) with the newly available oXiris haemofiltration membrane (ARTG ID 302001). The intervention is an approved device which is used in place of another approved device as part of usual care for acute kidney injury requiring renal replacement therapy. All intervention is provided in intensive care units (ICUs) by registered nurses with postgraduate qualifications in intensive care nursing. The intervention is provided individually and is required a variable number of times over a variable period (for example a median number of 3 haemofilter devices would be used over a period of 1 to 7 days). Renal replacement practices vary depending on the treating clinicians goals for therapy. This is unaffected by the intervention itself and the decision to commence CRRT is independent of the research study. Intervention adherence will be monitored by research staff at participating centres.


Locations(6)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

The Alfred - Melbourne

VIC, Australia

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

Dandenong Hospital - Dandenong

VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

VIC, Australia

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ACTRN12620000514909


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