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Cardiac FailurePhase 2BLENDERNCT03841084

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

A Phase 2 study testing Oxygen in people with Cardiac Failure and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Failure, Critical Illness
What is being tested?
Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteAustralia
Study dates
18 Sep 2019to 1 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥18 years who are commenced on V-A ECMO for severe cardiac, or following refractory cardiac arrest.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Australia1 site

  • Alfred Health

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

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

Read the 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.

Being tested
Oxygen
Keywords
ECMO, V-A ECMO, Oxygen, Hyperoxia
Medical subject headings
Heart Failure, Critical Illness, Hyperoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenDrug

    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

Study groups in NCT03841084
Study groupRoleWhat they receive
Conservative Oxygen Management StrategyActive comparatorPatients 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%.
Receives: Drug: Oxygen
Liberal Oxygen Management StrategyActive comparatorPatients 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).
Receives: Drug: Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at day 28

Secondary outcomes (7)

  1. Hospital mortality

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

    Measured: at day 28

  2. ICU mortality

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

    Measured: at day 28

  3. ICU length of stay

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

    Measured: at day 28

  4. Duration of mechanical ventilation

    Number of hours requiring mechanical ventilation from randomisation to day 28

    Measured: at day 28

  5. Disability

    World Health Organisation's Disability Assessment Schedule 2.0 12L

    Measured: 6 and 12 months

  6. 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.

    Measured: 6 and 12 months

  7. Psychological function at six and twelve months

    Measured using a trained, blinded assessor via telephone interview

    Measured: 6 months & 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start18 Sep 2019
  3. Primary completion3 Jun 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a phase II, registry-based, multicentre, parallel group randomised controlled trial. (Data retrieved from the EXCEL national clinical registry)
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841084
Sponsor's protocol ID
ANZIC-RC/DP001
Acronym
BLENDER
Status last verified
Aug 2024
First submitted
4 Feb 2019
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39705180

  • 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.

    PubMed 39162827

  • 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.

    PubMed 37876374

  • 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.

    PubMed 34914658

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxygen in people with Cardiac Failure and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome will be the number of alive and ICU-free days to day 28. (time frame: at day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03841084, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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