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

NCT03841084 | Completed Phase 2 DMC

• 1 other identifier: ANZIC-RC/DP001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Failure; Critical Illness

Keywords

ECMO; V-A ECMO; Oxygen; Hyperoxia

Outcome Measures

Primary Outcomes (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.

  at day 28

Secondary Outcomes (7)

• Hospital mortality

  at day 28

• ICU mortality

  at day 28

• ICU length of stay

  at day 28

• Duration of mechanical ventilation

  at day 28

• Disability

  6 and 12 months

Other Outcomes (1)

• ECMO circuit life

  day 28

Study Arms (2)

Conservative Oxygen Management Strategy

ACTIVE COMPARATOR

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%.

Drug: Oxygen

Liberal Oxygen Management Strategy

ACTIVE COMPARATOR

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).

Drug: Oxygen

Interventions

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

Conservative Oxygen Management Strategy; Liberal Oxygen Management Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Study Sites (1)

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Related Publications (3)

• 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.

  PMID: 39705180 DERIVED

• 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.

  PMID: 37876374 DERIVED

• 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.

  PMID: 34914658 DERIVED

MeSH Terms

Conditions

Heart Failure; Critical Illness; Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• David Pilcher

  Monash University, Australian & New Zealand Intensive Care research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase II, registry-based, multicentre, parallel group randomised controlled trial. (Data retrieved from the EXCEL national clinical registry)

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 15, 2019
• Study Start: September 18, 2019
• Primary Completion: June 3, 2023
• Study Completion: July 1, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)