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

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ClinicalTrials.gov Identifier: NCT03841084
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

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 60.

Condition or disease Intervention/treatment Phase
Cardiac Failure Critical Illness Drug: Oxygen Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Conservative Oxygen Management Strategy
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

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


Active Comparator: Liberal Oxygen Management Strategy
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

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 Outcome Measures :
  1. The primary outcome will be the number of alive and ICU-free days at day 60. [ Time Frame: at day 60 ]
    ICU free days are defined as the total number of days (or part days) being free of ICU between randomisation and day 60, with the exception that all patients who die by day 60 will be defined as having zero ICU free days.


Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: at day 60 ]
    Mortality rates of patients that day in hospital from randomisation to day 60

  2. ICU mortality [ Time Frame: at day 60 ]
    Mortality rates of patients that day in ICU from randomisation to day 60

  3. ICU length of stay [ Time Frame: at day 60 ]
    Number of hours spent in ICU from randomisation up to day 60

  4. Duration of mechanical ventilation [ Time Frame: at day 60 ]
    Number of hours requiring mechanical ventilation from randomisation to day 60

  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 Outcome Measures:
  1. ECMO circuit life [ Time Frame: day 60 ]
    number of hours that each circuit was in use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Patients ≥18 years who are commenced on V-A ECMO for severe cardiac and/or respiratory failure 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841084


Contacts
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Contact: Kelly Ottosen (03) 99030034 kelly.ottosen@monash.edu

Locations
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Australia, Victoria
Alfred Health Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Emma Martin    (03) 90768343    E.Martin2@alfred.org.au   
Principal Investigator: Aidan Burrell         
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Investigators
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Principal Investigator: David Pilcher Monash University, Australian & New Zealand Intensive Care research Centre
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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT03841084    
Other Study ID Numbers: ANZIC-RC/DP001
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
ECMO
V-A ECMO
Oxygen
Hyperoxia
Additional relevant MeSH terms:
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Heart Failure
Critical Illness
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases