Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial
- Registration Number
- NCT03841084
- 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 28.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
• Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, or following refractory cardiac arrest.
- 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)
- Patients who are already enrolled in another oxygen titration study (unless agreed by study committees)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conservative Oxygen Management Strategy Oxygen 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%. Liberal Oxygen Management Strategy Oxygen 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).
- Primary Outcome Measures
Name Time Method The primary outcome will be the number of alive and ICU-free days to day 28. 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.
- Secondary Outcome Measures
Name Time Method ICU mortality at day 28 Mortality rates of patients that day in ICU from randomisation to day 28
Disability 6 and 12 months World Health Organisation's Disability Assessment Schedule 2.0 12L
Hospital mortality at day 28 Mortality rates of patients that day in hospital from randomisation to day 28
ICU length of stay at day 28 Number of hours spent in ICU from randomisation up to day 28
Duration of mechanical ventilation at day 28 Number of hours requiring mechanical ventilation from randomisation to day 28
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
Trial Locations
- Locations (1)
Alfred Health
🇦🇺Melbourne, Victoria, Australia