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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05542966
Other study ID # HREC/50486/Alfred-2019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 18, 2022
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source Australian and New Zealand Intensive Care Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the BLENDER trial.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date August 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients receiving venoarterial (VA) ECMO - Enrolled in the BLENDER trial Exclusion Criteria: - Not enrolled in the BLENDER trial

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Alfred Hospital Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Australian and New Zealand Intensive Care Research Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Marker of Fibrinolysis Fibrinogen, Plasmin anti-plasmin complex, D-Dimer
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 3 of ECMO
Other Marker of Fibrinolysis Fibrinogen, Plasmin anti-plasmin complex, D-dimer
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 7 of ECMO
Primary 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 Within 24 hours of ECMO commencement
Secondary Marker of Cardiac Injury Troponin ng/ml
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 3 of ECMO
Secondary Marker of Cardiac Injury Troponin I ng/ml
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 7 of ECMO
Secondary Markers of Liver Injury ALT and AST (IU/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 3 of ECMO
Secondary Markers of Liver Injury ALT and AST (IU/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 7 of ECMO
Secondary Marker of Neurological Injury Neuron Specific Enolase (microg/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 3 of ECMO
Secondary Marker of Neurological Injury Neuron Specific Enolase (microg/L)
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 7 of ECMO
Secondary Coagulation Parameters APTT
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 3 of ECMO
Secondary Coagulation Parameters APTT
This will be determined by analysing blood samples routinely collected daily from patient receiving ECMO
Day 7 of ECMO
Secondary Immune Markers IL-6, TNFa, IL-10, IL-1B (pg/ml) Day 3 of ECMO
Secondary Immune Markers IL-6, TNFa, IL-10, IL-1B (pg/ml) Day 7 of ECMO
Secondary Other Markers of Oxidative Stress Malondialdehyde, Vitamin C Day 3 of ECMO
Secondary Other Markers of Oxidative Stress Malondialdehyde, Vitamin C Day 7 of ECMO
Secondary Superoxide dismutase levels U/ml Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO On Day 3 following ECMO commencement
Secondary Superoxide dismutase levels Plasma levels of superoxide dismutase in patients exposed to either a liberal or conservative oxygen strategy during VA-ECMO On Day 7 following ECMO commencement
Secondary Markers of Kidney Injury Creatinine (micromol/L) Day 3 of ECMO
Secondary Markers of Kidney Injury Creatinine (micromol/L) Day 7 of ECMO
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