NCT05542966

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

April 13, 2022

Last Update Submit

October 24, 2023

Conditions

Cardiac FailureCritical Illness

Keywords

ECMOV-A ECMOOxidative stressOxygenHyperoxia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Marker of Cardiac Injury

    Day 3 of ECMO

  • Marker of Cardiac Injury

    Day 7 of ECMO

  • Markers of Liver Injury

    Day 3 of ECMO

  • Markers of Liver Injury

    Day 7 of ECMO

  • Marker of Neurological Injury

    Day 3 of ECMO

  • +11 more secondary outcomes

Other Outcomes (2)

  • Marker of Fibrinolysis

    Day 3 of ECMO

  • Marker of Fibrinolysis

    Day 7 of ECMO

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

VA-ECMO patients enrolled in the BLENDER trial

You may qualify if:

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

You may not qualify if:

  • Not enrolled in the BLENDER trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Heart FailureCritical IllnessHyperoxia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2022

First Posted

September 16, 2022

Study Start

April 18, 2022

Primary Completion

August 3, 2023

Study Completion

December 31, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

AU(1)