- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03571074
Hyperoxia Before and After Cardiac Arrest and Myocardial Damage
Hyperoxia Before and After Cardiac Arrest and Myocardial Damage, a Retrospective Cohort Study
Several studies show how patients with hyperoxia after cardiac arrest has increased mortality, but the association of hyperoxia before cardiac arrest and myocardial damage has never been investigated. Neither has the association between hyperoxia after cardiac arrest and myocardial injury.
Our research hypothesis is that hyperoxia before cardiac arrest aggravates myocardial damage, secondly we wish to analyze the association between hyperoxia after cardiac arrest and myocardial injury.
The exposure variables is oxygenation within 48 hours before and 48 hours after cardiac arrest, our primary outcome is myocardial damage and will be measured as peak troponin within 30 days after cardiac arrest.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2400
- Bispebjerg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older
- With a record of ICD-10 diagnosis of cardiac arrest in 2014, admitted to a hospital in the Capital Region of Denmark.
- First recorded cardiac arrest in 2014
- Admitted to ICU
- Serum troponin measured within 7 days after cardiac arrest
Exclusion Criteria:
- Out of hospital cardiac arrest, OHCA
- In of hospital cardiac arrest, IHCA, but with no registered saturation before cardiac arrest.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hypoxia
Defined as a group of patients with oxygen saturation <94 % irrespective of supplemental oxygen. If COPD, defined as oxygen saturation <88 % irrespective of supplemental oxygen. |
Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.
|
Normoxia
Defined as a group of patients with oxygen saturation 94 % - 98 % in combination of supplemental oxygen, or oxygen saturation >94 % without supplemental oxygen. If COPD, defined as oxygen saturation 88 % - 92 % in combination of supplemental oxygen, or oxygen saturation >88 % without supplemental oxygen. |
Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.
|
Hyperoxia
Defined as a group of patients with oxygen saturation >98 % in combination of supplemental oxygen. If COPD, defined as oxygen saturation >92 % in combination of supplemental oxygen. |
Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak troponin within 30 days after cardiac arrest
Time Frame: 30 days
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Troponin measurements on patients after cardiac arrest.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
30-day and 1-year mortality
Time Frame: Up to 1 year.
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Up to 1 year.
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Troponin area under the curve within 3 days after cardiac arrest
Time Frame: 3 days
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3 days
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Length of ICU stay after cardiac arrest
Time Frame: through study completion,on average of 4-8 weeks.
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through study completion,on average of 4-8 weeks.
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Length of hospital stay after cardiac arrest
Time Frame: through study completion,on average of 4-8 weeks.
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through study completion,on average of 4-8 weeks.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HyperoxiaandCardiacarrest
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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