Clinical trial NCT03841084: Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial
Official title: Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Failure
Critical Illness
Keywords: ECMO
V-A ECMO
Oxygen
Hyperoxia
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase II, registry-based, multicentre, parallel group randomised controlled trial.

(Data retrieved from the EXCEL national clinical registry)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome will be the number of alive and ICU-free days to day 28.
timeFrame: at day 28
Secondary outcomes:
measure: Hospital mortality
timeFrame: at day 28
measure: ICU mortality
timeFrame: at day 28
measure: ICU length of stay
timeFrame: at day 28
measure: Duration of mechanical ventilation
timeFrame: at day 28
measure: Disability
timeFrame: 6 and 12 months
measure: Health-related quality of life at six and twelve months using the EQ5D-5L
timeFrame: 6 and 12 months
measure: Psychological function at six and twelve months
timeFrame: 6 months & 12 months
Other outcomes:
measure: ECMO circuit life
timeFrame: day 28
Locations:
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
Study officials:
affiliation: Monash University, Australian & New Zealand Intensive Care research Centre
name: David Pilcher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.