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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05542966
• Other study ID #: HREC/50486/Alfred-2019
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Failure
• Critical Illness
• Heart Failure

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