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

Primary Purpose

Cardiac Failure, Critical Illness

Status
Recruiting
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Oxygen
Sponsored by
Australian and New Zealand Intensive Care Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Failure focused on measuring ECMO, V-A ECMO, Oxygen, Hyperoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alfred HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conservative Oxygen Management Strategy

Liberal Oxygen Management Strategy

Arm Description

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%.

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).

Outcomes

Primary Outcome Measures

The primary outcome will be the number of alive and ICU-free days 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

Hospital mortality
Mortality rates of patients that day in hospital from randomisation to day 60
ICU mortality
Mortality rates of patients that day in ICU from randomisation to day 60
ICU length of stay
Number of hours spent in ICU from randomisation up to day 60
Duration of mechanical ventilation
Number of hours requiring mechanical ventilation from randomisation to day 60
Disability
World Health Organisation's Disability Assessment Schedule 2.0 12L
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.
Psychological function at six and twelve months
Measured using a trained, blinded assessor via telephone interview

Full Information

First Posted
February 4, 2019
Last Updated
March 20, 2023
Sponsor
Australian and New Zealand Intensive Care Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03841084
Brief Title
Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial
Acronym
BLENDER
Official Title
Blend to Limit oxygEN in ECMO: a ranDomised controllEd Registry Trial The BLENDER Trial - A Phase II Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Intensive Care Research Centre

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure, Critical Illness
Keywords
ECMO, V-A ECMO, Oxygen, Hyperoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative Oxygen Management Strategy
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Liberal Oxygen Management Strategy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
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 Measure Information:
Title
The primary outcome will be the number of alive and ICU-free days at day 60.
Description
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.
Time Frame
at day 60
Secondary Outcome Measure Information:
Title
Hospital mortality
Description
Mortality rates of patients that day in hospital from randomisation to day 60
Time Frame
at day 60
Title
ICU mortality
Description
Mortality rates of patients that day in ICU from randomisation to day 60
Time Frame
at day 60
Title
ICU length of stay
Description
Number of hours spent in ICU from randomisation up to day 60
Time Frame
at day 60
Title
Duration of mechanical ventilation
Description
Number of hours requiring mechanical ventilation from randomisation to day 60
Time Frame
at day 60
Title
Disability
Description
World Health Organisation's Disability Assessment Schedule 2.0 12L
Time Frame
6 and 12 months
Title
Health-related quality of life at six and twelve months using the EQ5D-5L
Description
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.
Time Frame
6 and 12 months
Title
Psychological function at six and twelve months
Description
Measured using a trained, blinded assessor via telephone interview
Time Frame
6 months & 12 months
Other Pre-specified Outcome Measures:
Title
ECMO circuit life
Description
number of hours that each circuit was in use
Time Frame
day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Ottosen
Phone
(03) 99030034
Email
kelly.ottosen@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pilcher
Organizational Affiliation
Monash University, Australian & New Zealand Intensive Care research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Martin
Phone
(03) 90768343
Email
E.Martin2@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Aidan Burrell

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34914658
Citation
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.
Results Reference
derived

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

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