Cardiac FailureNCT05542966
Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
An observational study of Cardiac Failure and Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
Trial summary
To compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Failure, Critical Illness
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Apr 2022to 31 Dec 2023
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VA-ECMO patients enrolled in the BLENDER trial
Who may be able to join
- Patients receiving venoarterial (VA) ECMO
- Enrolled in the BLENDER trial
Who cannot join
- Not enrolled in the BLENDER trial
Trial locations and contacts
1 site in 1 country.
About this study
To compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial.
Read the detailed description
Extracorporeal membrane oxygen (ECMO) is a heart lung support device used for patients with severe and cardiac and respiratory failure and carries an increased risk of exposure to very high oxygen tensions. Hyperoxia (arterial oxygen >100mmHg) can lead to the production of reactive oxygen species (ROS). Excess production of ROS and depletion of antioxidant compounds is referred to as oxidative stress and results in inflammation, tissue injury and cell death. The inter-relationship between the production of ROS and end organ dysfunction is complicated and remain unclear. A more detailed assessment of the timing of changes in markers of oxidative stress, inflammatory mediators and tissue injury is warranted to understand the processes and potentially identify therapeutic targets.
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. Currently there have been no studies that look at the underlying pathophysiological changes that occur in patients on ECMO when subjected to different oxygen concentrations. As such The BLENDER study represents a unique opportunity to understand the mechanisms by which hyperoxia may cause tissue injury in patients receiving ECMO. This nested study seeks to elucidate whether exposure to hyperoxia during ECMO results in increased oxidative stress and whether this is correlated with increased risk of tissue injury and organ dysfunction. A better understanding of the mechanism of hyperoxia induced tissue injury may allow treatment to be optimised for patients exposed to hyperoxia as part of their treatment.
- Conditions
- Cardiac Failure, Critical Illness
- Keywords
- ECMO, V-A ECMO, Oxidative stress, Oxygen, Hyperoxia
- Medical subject headings
- Heart Failure, Critical Illness, Hyperoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Super oxide dismutase levels U/ml
Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
Measured: Within 24 hours of ECMO commencement
Secondary outcomes (16)
Marker of Cardiac Injury
Troponin ng/ml
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 3 of ECMO
Marker of Cardiac Injury
Troponin I ng/ml
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 7 of ECMO
Markers of Liver Injury
ALT and AST (IU/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 3 of ECMO
Markers of Liver Injury
ALT and AST (IU/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 7 of ECMO
Marker of Neurological Injury
Neuron Specific Enolase (microg/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 3 of ECMO
Marker of Neurological Injury
Neuron Specific Enolase (microg/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 7 of ECMO
Coagulation Parameters
APTT
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 3 of ECMO
Coagulation Parameters
APTT
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Measured: Day 7 of ECMO
Immune Markers
IL-6, TNFa, IL-10, IL-1B (pg/ml)
Measured: Day 3 of ECMO
Immune Markers
IL-6, TNFa, IL-10, IL-1B (pg/ml)
Measured: Day 7 of ECMO
Other Markers of Oxidative Stress
Malondialdehyde, Vitamin C
Measured: Day 3 of ECMO
Other Markers of Oxidative Stress
Malondialdehyde, Vitamin C
Measured: Day 7 of ECMO
Superoxide dismutase levels U/ml
Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
Measured: On Day 3 following ECMO commencement
Superoxide dismutase levels
Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
Measured: On Day 7 following ECMO commencement
Markers of Kidney Injury
Creatinine (micromol/L)
Measured: Day 3 of ECMO
Markers of Kidney Injury
Creatinine (micromol/L)
Measured: Day 7 of ECMO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start18 Apr 2022
- Primary completion3 Aug 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542966
- Sponsor's protocol ID
- HREC/50486/Alfred-2019
- Status last verified
- Oct 2023
- First submitted
- 13 Apr 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
- ClinicalTrials.gov ID
- NCT05542966
- Acronym / sponsor ID
- HREC/50486/Alfred-2019
- Conditions
- Cardiac Failure, Critical Illness
- Keywords
- ECMO, V-A ECMO, Oxidative stress, Oxygen, Hyperoxia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial.
Detailed description
Extracorporeal membrane oxygen (ECMO) is a heart lung support device used for patients with severe and cardiac and respiratory failure and carries an increased risk of exposure to very high oxygen tensions. Hyperoxia (arterial oxygen >100mmHg) can lead to the production of reactive oxygen species (ROS). Excess production of ROS and depletion of antioxidant compounds is referred to as oxidative stress and results in inflammation, tissue injury and cell death. The inter-relationship between the production of ROS and end organ dysfunction is complicated and remain unclear. A more detailed assessment of the timing of changes in markers of oxidative stress, inflammatory mediators and tissue injury is warranted to understand the processes and potentially identify therapeutic targets.
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. Currently there have been no studies that look at the underlying pathophysiological changes that occur in patients on ECMO when subjected to different oxygen concentrations. As such The BLENDER study represents a unique opportunity to understand the mechanisms by which hyperoxia may cause tissue injury in patients receiving ECMO. This nested study seeks to elucidate whether exposure to hyperoxia during ECMO results in increased oxidative stress and whether this is correlated with increased risk of tissue injury and organ dysfunction. A better understanding of the mechanism of hyperoxia induced tissue injury may allow treatment to be optimised for patients exposed to hyperoxia as part of their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VA-ECMO patients enrolled in the BLENDER trial
Key inclusion criteria (2 listed)
- Patients receiving venoarterial (VA) ECMO
- Enrolled in the BLENDER trial
Key exclusion criteria (1 listed)
- Not enrolled in the BLENDER trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Super oxide dismutase levels U/ml
Time frame: Within 24 hours of ECMO commencement
Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
16 secondary outcomes
Marker of Cardiac Injury
Time frame: Day 3 of ECMO
Marker of Cardiac Injury
Time frame: Day 7 of ECMO
Markers of Liver Injury
Time frame: Day 3 of ECMO
Markers of Liver Injury
Time frame: Day 7 of ECMO
Marker of Neurological Injury
Time frame: Day 3 of ECMO
Marker of Neurological Injury
Time frame: Day 7 of ECMO
Coagulation Parameters
Time frame: Day 3 of ECMO
Coagulation Parameters
Time frame: Day 7 of ECMO
Immune Markers
Time frame: Day 3 of ECMO
Immune Markers
Time frame: Day 7 of ECMO
Other Markers of Oxidative Stress
Time frame: Day 3 of ECMO
Other Markers of Oxidative Stress
Time frame: Day 7 of ECMO
Superoxide dismutase levels U/ml
Time frame: On Day 3 following ECMO commencement
Superoxide dismutase levels
Time frame: On Day 7 following ECMO commencement
Markers of Kidney Injury
Time frame: Day 3 of ECMO
Markers of Kidney Injury
Time frame: Day 7 of ECMO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2023. 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.
Are results available for this study?
Results are not available in the source record.
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?
Super oxide dismutase levels U/ml (time frame: Within 24 hours of ECMO commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.