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Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury

Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05542966
Enrollment
30
Registered
2022-09-16
Start date
2022-04-18
Completion date
2023-12-31
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Failure, Critical Illness

Keywords

ECMO, V-A ECMO, Oxidative stress, Oxygen, Hyperoxia

Brief summary

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.

Interventions

None listed

Sponsors

Australian and New Zealand Intensive Care Research Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients receiving venoarterial (VA) ECMO * Enrolled in the BLENDER trial

Exclusion criteria

* Not enrolled in the BLENDER trial

Design outcomes

Primary

MeasureTime frameDescription
Super oxide dismutase levels U/mlWithin 24 hours of ECMO commencementPlasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO

Secondary

MeasureTime frameDescription
Superoxide dismutase levelsOn Day 7 following ECMO commencementPlasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
Markers of Kidney InjuryDay 3 of ECMOCreatinine (micromol/L)
Marker of Cardiac InjuryDay 3 of ECMOTroponin ng/ml This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Markers of Liver InjuryDay 3 of ECMOALT and AST (IU/L) This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Coagulation ParametersDay 3 of ECMOAPTT This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Immune MarkersDay 3 of ECMOIL-6, TNFa, IL-10, IL-1B (pg/ml)
Other Markers of Oxidative StressDay 3 of ECMOMalondialdehyde, Vitamin C
Superoxide dismutase levels U/mlOn Day 3 following ECMO commencementPlasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO
Marker of Neurological InjuryDay 3 of ECMONeuron Specific Enolase (microg/L) This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO

Other

MeasureTime frameDescription
Marker of FibrinolysisDay 3 of ECMOFibrinogen, Plasmin anti-plasmin complex, D-Dimer This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026