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Completed

NCT Number: NCT03841084

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alfred Health

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The primary outcome will be the number of alive and ICU-free days to day 28.

    Time frame: 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 outcomes

  1. Hospital mortality

    Time frame: at day 28

    Mortality rates of patients that day in hospital from randomisation to day 28

  2. ICU mortality

    Time frame: at day 28

    Mortality rates of patients that day in ICU from randomisation to day 28

  3. ICU length of stay

    Time frame: at day 28

    Number of hours spent in ICU from randomisation up to day 28

  4. Duration of mechanical ventilation

    Time frame: at day 28

    Number of hours requiring mechanical ventilation from randomisation to day 28

  5. Disability

    Time frame: 6 and 12 months

    World Health Organisation's Disability Assessment Schedule 2.0 12L

  6. Health-related quality of life at six and twelve months using the EQ5D-5L

    Time frame: 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.

  7. Psychological function at six and twelve months

    Time frame: 6 months & 12 months

    Measured using a trained, blinded assessor via telephone interview

Other outcomes

  1. ECMO circuit life

    Time frame: day 28

    number of hours that each circuit was in use

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Registry information

Official study title

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

Acronym: BLENDER

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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