None listed
Conditions
Brief 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.
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 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 require
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.
Sponsors
Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria (must have 1 + 2 +3) 1. Sepsis, as defined by: 1.1. Suspected or documented infection AND 1.2. An acute increase of greater than 2 SOFA points consequent to the infection (indicating organ dysfunction) 2. Septic shock, as defined by: 2.1. 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 2.2. Lactate greater than 2 mmol/L after volume resuscitation at any time in the preceding 24 hours 3. Acute kidney injury with the requirement for CRRT to control one or more of: 3.1. Volume status/fluid overload 3.2. Hyperkalaemia 3.3. Metabolic acidosis 3.4. Uraemia
Exclusion criteria
• 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
Outcome results
None listed