Hyperoxia Before and After Cardiac Arrest and Myocardial Damage
1 other identifier
observational
163
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedOctober 23, 2018
October 1, 2018
2 months
June 4, 2018
October 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Peak troponin within 30 days after cardiac arrest
Troponin measurements on patients after cardiac arrest.
30 days
Secondary Outcomes (4)
30-day and 1-year mortality
Up to 1 year.
Troponin area under the curve within 3 days after cardiac arrest
3 days
Length of ICU stay after cardiac arrest
through study completion,on average of 4-8 weeks.
Length of hospital stay after cardiac arrest
through study completion,on average of 4-8 weeks.
Study Arms (3)
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.
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.
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.
Interventions
Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.
Eligibility Criteria
Patients with in hospital cardiac arrest, who had return of spontaneus circulaiton and was then admitted to ICU in a hospital in the Capital Region of Denmark.
You may qualify if:
- 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
You may not qualify if:
- Out of hospital cardiac arrest, OHCA
- In of hospital cardiac arrest, IHCA, but with no registered saturation before cardiac arrest.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant, Bispebjerg Hospital.
Study Record Dates
First Submitted
June 4, 2018
First Posted
June 27, 2018
Study Start
May 30, 2018
Primary Completion
August 10, 2018
Study Completion
September 30, 2018
Last Updated
October 23, 2018
Record last verified: 2018-10