Alfred Health
Melbourne, Victoria, 3004, Australia
NCT Number: NCT03841084
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Melbourne, Victoria, 3004, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: at 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
Mortality rates of patients that day in hospital from randomisation to day 28
Time frame: at day 28
Mortality rates of patients that day in ICU from randomisation to day 28
Time frame: at day 28
Number of hours spent in ICU from randomisation up to day 28
Time frame: at day 28
Number of hours requiring mechanical ventilation from randomisation to day 28
Time frame: 6 and 12 months
World Health Organisation's Disability Assessment Schedule 2.0 12L
Time frame: 6 and 12 months
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.
Time frame: 6 months & 12 months
Measured using a trained, blinded assessor via telephone interview
Time frame: day 28
number of hours that each circuit was in use
Australian and New Zealand Intensive Care Research Centre
Other
Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial
Acronym: BLENDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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