BLENDER: Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial
Study Details
Study Description
Brief Summary
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 60.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Conservative Oxygen Management Strategy Patients allocated to the conservative strategy will have the ECMO blender oxygen fraction (FbO2) will be titrated to achieve a post-oxygenator saturations of 92-96% (the FbO2 cannot be reduced to lower than 0.5). Post-oxygenator arterial blood gases (ABG's) will be taken to ensure safety and to allow for adjustments to be made. The ventilator FiO2 will be titrated to patient oxygen saturations (SpO2) of 92-96%. |
Drug: Oxygen
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
|
Active Comparator: Liberal Oxygen Management Strategy Patients allocated to the liberal strategy will have the FbO2 set at 1.0 at all times. The ventilator FiO2 will be titrated to achieve a patient oxygen saturations (SpO2) of 97-100% (but not lower than 0.5). |
Drug: Oxygen
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
|
Outcome Measures
Primary Outcome Measures
- The primary outcome will be the number of alive and ICU-free days at day 60. [at day 60]
ICU free days are defined as the total number of days (or part days) being free of ICU between randomisation and day 60, with the exception that all patients who die by day 60 will be defined as having zero ICU free days.
Secondary Outcome Measures
- Hospital mortality [at day 60]
Mortality rates of patients that day in hospital from randomisation to day 60
- ICU mortality [at day 60]
Mortality rates of patients that day in ICU from randomisation to day 60
- ICU length of stay [at day 60]
Number of hours spent in ICU from randomisation up to day 60
- Duration of mechanical ventilation [at day 60]
Number of hours requiring mechanical ventilation from randomisation to day 60
- Disability [6 and 12 months]
World Health Organisation's Disability Assessment Schedule 2.0 12L
- Health-related quality of life at six and twelve months using the EQ5D-5L [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.
- Psychological function at six and twelve months [6 months & 12 months]
Measured using a trained, blinded assessor via telephone interview
Other Outcome Measures
- ECMO circuit life [day 60]
number of hours that each circuit was in use
Eligibility Criteria
Criteria
Inclusion Criteria:
• Patients ≥18 years who are commenced on V-A ECMO for severe cardiac and/or respiratory failure or following refractory cardiac arrest.
Exclusion Criteria:
-
Greater than 6 hours have elapsed from the time of initiation of ECMO to randomisation
-
Patients who are suspected or confirmed to be pregnant
-
Where an indication exists for a specific oxygen target as part of clinical care (e.g. carbon monoxide poisoning)
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Patients who are already enrolled in another oxygen titration study
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Patients not willing to receive blood products (e.g. Jehovah's Witness)
-
Where the treating physician deems the study is not in the patient's best interest
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alfred Health | Melbourne | Victoria | Australia | 3004 |
Sponsors and Collaborators
- Australian and New Zealand Intensive Care Research Centre
Investigators
- Principal Investigator: David Pilcher, Monash University, Australian & New Zealand Intensive Care research Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANZIC-RC/DP001