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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Oxygen Management Strategy | Active Comparator | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality | Mortality rates of patients that day in hospital from randomisation to day 28 | at day 28 |
| ICU mortality | Mortality rates of patients that day in ICU from randomisation to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| ECMO circuit life | number of hours that each circuit was in use | day 28 |
Inclusion Criteria:
• Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, or following refractory cardiac arrest.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Pilcher | Monash University, Australian & New Zealand Intensive Care research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39705180 | Derived | Gu WJ, Shi R, Cen Y, Ye YY, Xie XD, Yin HY. Association Between Arterial Hyperoxia and Mortality in Pediatric and Adult Patients Undergoing Extracorporeal Membrane Oxygenation: A Systematic Review and Meta-Analysis. Anesth Analg. 2025 Jun 1;140(6):1367-1376. doi: 10.1213/ANE.0000000000007348. Epub 2024 Dec 20. | |
| 39162827 | Derived |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D016638 | Critical Illness |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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This is a phase II, registry-based, multicentre, parallel group randomised controlled trial.
(Data retrieved from the EXCEL national clinical registry)
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| at day 28 |
| ICU length of stay | Number of hours spent in ICU from randomisation up to day 28 | at day 28 |
| Duration of mechanical ventilation | Number of hours requiring mechanical ventilation from randomisation to day 28 | at day 28 |
| Disability | World Health Organisation's Disability Assessment Schedule 2.0 12L | 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. | 6 and 12 months |
| Psychological function at six and twelve months | Measured using a trained, blinded assessor via telephone interview | 6 months & 12 months |
| Burrell A, Bailey MJ, Bellomo R, Buscher H, Eastwood G, Forrest P, Fraser JF, Fulcher B, Gattas D, Higgins AM, Hodgson CL, Litton E, Martin EL, Nair P, Ng SJ, Orford N, Ottosen K, Paul E, Pellegrino V, Reid L, Shekar K, Totaro RJ, Trapani T, Udy A, Ziegenfuss M, Pilcher D; BLENDER Trial Investigators, EXCEL Registry, ECMONet and the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group and Centre for Outcomes and Resource Evaluation. Conservative or liberal oxygen targets in patients on venoarterial extracorporeal membrane oxygenation. Intensive Care Med. 2024 Sep;50(9):1470-1483. doi: 10.1007/s00134-024-07564-8. Epub 2024 Aug 20. |
| 37876374 | Derived | Burrell A, Ng S, Ottosen K, Bailey M, Buscher H, Fraser J, Udy A, Gattas D, Totaro R, Bellomo R, Forrest P, Martin E, Reid L, Ziegenfuss M, Eastwood G, Higgins A, Hodgson C, Litton E, Nair P, Orford N, Pellegrino V, Shekar K, Trapani T, Pilcher D. Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan. Crit Care Resusc. 2023 Aug 4;25(3):118-125. doi: 10.1016/j.ccrj.2023.06.001. eCollection 2023 Sep. |
| 34914658 | Derived | Joyce CJ, Anderson C, Shekar K. Hyperoxia on Venoarterial Extracorporeal Membrane Oxygenation: A Modifiable Risk? Crit Care Med. 2022 Jan 1;50(1):e99-e100. doi: 10.1097/CCM.0000000000005252. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |