Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial (BLENDER)

Australian and New Zealand Intensive Care Research Centre

Status and phase: Completed; Phase 2

Conditions: Cardiac Failure; Critical Illness

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT03841084

ANZIC-RC/DP001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, 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)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Conservative Oxygen Management Strategy

Active Comparator group

Description:

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%.

Treatment:

Drug: Oxygen

Liberal Oxygen Management Strategy

Active Comparator group

Description:

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).

Treatment:

Drug: Oxygen