NCT03571074

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

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

June 4, 2018

Last Update Submit

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.

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.

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.

Other: Oxygenation

Interventions

Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.

HyperoxiaHypoxiaNormoxia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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

Locations