To determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative as compared with liberal oxygen strategy, results in a greater number of ICU-free days at day 28.
Extracorporeal membrane oxygenation (ECMO) can be a lifesaving procedure for the sickest patients in the Intensive Care Unit (ICU) who are at risk of death from severe cardiac and respiratory failure. ECMO is a device which pumps blood out of the body and returns it back after adding oxygen and removing carbon dioxide. While potentially life-saving, ECMO is associated with high use of critical care resources and increased risk of adverse outcomes in survivors. The BLENDER Trial is a multicentre trial in ECMO patients to determine whether a conservative oxygen strategy during ECMO reduces ICU length of stay and improves patient outcomes compared to a liberal oxygen strategy. Both strategies are currently standard practice worldwide, however, there is no consensus to which strategy is better for our patients. This trial aims to utilise an existing intensive care registry and will recruit 300 patients with life threatening acute cardiac or respiratory failure. If the BLENDER Trial confirms that one oxygen management strategy is more effective than the other, its findings may improve the lives of critically ill Australians and inform clinical practice worldwide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Conservative oxygen management strategy- reduces oxygen on the inoblender in the ECMO circuit. Liberal oxygen management strategy - does not reduce the oxygen on the inoblender via the ECMO circuit
Alfred Health
Melbourne, Victoria, Australia
The primary outcome will be the number of alive and ICU-free days to day 28.
ICU free days are defined as the total number of days (or part days) being free of ICU between randomisation and day 28, with the exception that all patients who die by day 28 will be defined as having zero ICU free days.
Time frame: at day 28
Hospital mortality
Mortality rates of patients that day in hospital from randomisation to day 28
Time frame: at day 28
ICU mortality
Mortality rates of patients that day in ICU from randomisation to day 28
Time frame: at day 28
ICU length of stay
Number of hours spent in ICU from randomisation up to day 28
Time frame: at day 28
Duration of mechanical ventilation
Number of hours requiring mechanical ventilation from randomisation to day 28
Time frame: at day 28
Disability
World Health Organisation's Disability Assessment Schedule 2.0 12L
Time frame: 6 and 12 months
Health-related quality of life at six and twelve months using the EQ5D-5L
Euro Qol Group Health Survey (EQ-5D-5L) Measuring quality of life which looks at five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
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Time frame: 6 and 12 months
Psychological function at six and twelve months
Measured using a trained, blinded assessor via telephone interview
Time frame: 6 months & 12 months