Cardiac ArrestNCT03571074
Hyperoxia Before and After Cardiac Arrest and Myocardial Damage
An observational study of Cardiac Arrest, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Oxygenation
- How many people
- 163 participants
- Where
- 1 siteDenmark
- Study dates
- 30 May 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Out of hospital cardiac arrest, OHCA
- In of hospital cardiac arrest, IHCA, but with no registered saturation before cardiac arrest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiac Arrest
- Being tested
- Oxygenation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenationOther
Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Oxygenation | |
| 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. Receives: Other: Oxygenation | |
| 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. Receives: Other: Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak troponin within 30 days after cardiac arrest
Troponin measurements on patients after cardiac arrest.
Measured: 30 days
Secondary outcomes (4)
30-day and 1-year mortality
Measured: Up to 1 year.
Troponin area under the curve within 3 days after cardiac arrest
Measured: 3 days
Length of ICU stay after cardiac arrest
Measured: through study completion,on average of 4-8 weeks.
Length of hospital stay after cardiac arrest
Measured: through study completion,on average of 4-8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start30 May 2018
- Primary completion10 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathrine Schmidt Groenbek, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571074
- Sponsor's protocol ID
- HyperoxiaandCardiacarrest
- Status last verified
- Oct 2018
- First submitted
- 4 Jun 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia Before and After Cardiac Arrest and Myocardial Damage, a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03571074
- Acronym / sponsor ID
- HyperoxiaandCardiacarrest
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | – | Other: OxygenationDefined 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 | – | Other: OxygenationDefined 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 | – | Other: OxygenationDefined 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Out of hospital cardiac arrest, OHCA
- In of hospital cardiac arrest, IHCA, but with no registered saturation before cardiac arrest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenationOxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest. | Other | Hyperoxia, Hypoxia, Normoxia |
Primary outcome
Peak troponin within 30 days after cardiac arrest
Time frame: 30 days
Troponin measurements on patients after cardiac arrest.
4 secondary outcomes
30-day and 1-year mortality
Time frame: Up to 1 year.
Troponin area under the curve within 3 days after cardiac arrest
Time frame: 3 days
Length of ICU stay after cardiac arrest
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak troponin within 30 days after cardiac arrest (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.