Clinical trial NCT05542966: Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
Official title: Blender Biomarkers: A BLENDER Sub-study to Evaluate the Effect of Oxygen Dose on Oxidative Stress and Organ Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Failure
Critical Illness
Keywords: ECMO
V-A ECMO
Oxidative stress
Oxygen
Hyperoxia
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: VA-ECMO patients enrolled in the BLENDER trial

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not enrolled in the BLENDER trial

Primary outcomes:
measure: Super oxide dismutase levels U/ml
timeFrame: Within 24 hours of ECMO commencement
Secondary outcomes:
measure: Marker of Cardiac Injury
timeFrame: Day 3 of ECMO
measure: Marker of Cardiac Injury
timeFrame: Day 7 of ECMO
measure: Markers of Liver Injury
timeFrame: Day 3 of ECMO
measure: Markers of Liver Injury
timeFrame: Day 7 of ECMO
measure: Marker of Neurological Injury
timeFrame: Day 3 of ECMO
measure: Marker of Neurological Injury
timeFrame: Day 7 of ECMO
measure: Coagulation Parameters
timeFrame: Day 3 of ECMO
measure: Coagulation Parameters
timeFrame: Day 7 of ECMO
measure: Immune Markers
timeFrame: Day 3 of ECMO
measure: Immune Markers
timeFrame: Day 7 of ECMO
measure: Other Markers of Oxidative Stress
timeFrame: Day 3 of ECMO
measure: Other Markers of Oxidative Stress
timeFrame: Day 7 of ECMO
measure: Superoxide dismutase levels U/ml
timeFrame: On Day 3 following ECMO commencement
measure: Superoxide dismutase levels
timeFrame: On Day 7 following ECMO commencement
measure: Markers of Kidney Injury
timeFrame: Day 3 of ECMO
measure: Markers of Kidney Injury
timeFrame: Day 7 of ECMO
Other outcomes:
measure: Marker of Fibrinolysis
timeFrame: Day 3 of ECMO
measure: Marker of Fibrinolysis
timeFrame: Day 7 of ECMO
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
References: