None listed
Conditions
Brief summary
We are conducting a pilot, safety, feasibility, efficacy, crossover, open-label randomised controlled trial, of 20 adult critically ill patients, in the Departments of Intensive Care at the Austin Hospital and Bordeaux University Hospital. Continuous renal replacement therapy (CRRT), an artificial means of providing kidney function support, is often required in acutely ill patients who are admitted to the intensive care unit (ICU). The aim of CRRT is to achieve adequate blood purification from kidney failure associated toxins (typically non-protein bound small solutes). However, there are additional toxins that are related to liver failure, which should be a target for effective removal but cannot be effectively removed by (e.g. ammonia and/or bilirubin) during the current approach to CRRT. In patients experiencing liver failure that is also complicated by kidney failure, an additional form of blood purification that can be easily added to the CRRT circuit would be desirable. Such blood purification is now available in the form of hemoperfusion (HP). It consists of a biocompatible coated resin inside a cartridge, which can adsorb large amounts of multiple toxins even when they are protein bound. This new technology has now been used to treat patients with septic shock, COVID-19-related acute respiratory distress syndrome (ARDS) and hyperinflammation as well as the itch associated with end stage kidney disease and advance liver disease. The added form of hemoperfusion offers much promise as a way of detoxifying plasma in acutely ill liver patients admitted to ICU with kidney failure.
Interventions
Following confirmation of eligibility and randomisation, a member of the investigating team will either add a hemoperfusion cartridge (HA330-II Jafron, Guangdong, China) for 12 hours and then changed to a new cartridge for a total of 2 cartridges over 24 hours of treatment for enrolled participants who receive standard continuous renal replacement therapy therapy in the intensive care unit, followed or preceded (by random allocation) the use of the standard care hemofiltration cartridge without
Following confirmation of eligibility and randomisation, a member of the investigating team will either add a hemoperfusion cartridge (HA330-II Jafron, Guangdong, China) for 12 hours and then changed to a new cartridge for a total of 2 cartridges over 24 hours of treatment for enrolled participants who receive standard continuous renal replacement therapy therapy in the intensive care unit, followed or preceded (by random allocation) the use of the standard care hemofiltration cartridge without a washout period during continuous renal replacement therapy.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Liver failure and severe acute kidney injury requiring continuous renal replacement therapy Expected to continue to receive continuous renal replacement therapy for equal to or greater than 48 hours from the time of enrolment
Exclusion criteria
Suspected or confirmed pregnancy Do not resuscitate (DNR) order in place Do not intubate (DNI) order in place Death is deemed inevitable or imminent during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment Known human immunodeficiency virus (HIV) infection Another illness is present that in the investigator’s judgement, will substantially increase the risk associated with the participants participant in the study
Outcome results
None listed