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

Critical Illness Clinical Trial

— BLENDER  

Official title:

Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03841084
• Other study ID #: ANZIC-RC/DP001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 18, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 31, 2024
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Failure
• Critical Illness
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ECMO circuit life	number of hours that each circuit was in use	day 28
Primary	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
Secondary	Hospital mortality	Mortality rates of patients that day in hospital from randomisation to day 28	at day 28
Secondary	ICU mortality	Mortality rates of patients that day in ICU from randomisation to day 28	at day 28
Secondary	ICU length of stay	Number of hours spent in ICU from randomisation up to day 28	at day 28
Secondary	Duration of mechanical ventilation	Number of hours requiring mechanical ventilation from randomisation to day 28	at day 28
Secondary	Disability	World Health Organisation's Disability Assessment Schedule 2.0 12L	6 and 12 months
Secondary	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
Secondary	Psychological function at six and twelve months	Measured using a trained, blinded assessor via telephone interview	6 months & 12 months