Hyperoxia Before and After Cardiac Arrest and Myocardial Damage

October 20, 2018 updated by: Kathrine Schmidt Groenbek, University Hospital Bispebjerg and Frederiksberg

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Troponin measurements on patients after cardiac arrest.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
30-day and 1-year mortality
Time Frame: Up to 1 year.
Up to 1 year.
Troponin area under the curve within 3 days after cardiac arrest
Time Frame: 3 days
3 days
Length of ICU stay after cardiac arrest
Time Frame: through study completion,on average of 4-8 weeks.
through study completion,on average of 4-8 weeks.
Length of hospital stay after cardiac arrest
Time Frame: through study completion,on average of 4-8 weeks.
through study completion,on average of 4-8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 30, 2018

Primary Completion (ACTUAL)

August 10, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 17, 2018

First Posted (ACTUAL)

June 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 20, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HyperoxiaandCardiacarrest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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