NCT01881243

Brief Summary

The broad objective of this study is to test the association between hyperoxia exposure after resuscitation from cardiac arrest and outcome. Our overarching hypothesis is that hyperoxia after ROSC is associated with increased oxidative stress and worsened neurological and cognitive outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

4 years

First QC Date

June 17, 2013

Last Update Submit

November 22, 2019

Conditions

Keywords

Cardiac Arrest, Hyperoxia, Ischemia-reperfusion Injury, Reactive Oxygen Species, Oxidative Stress, Neuropsychological Tests

Outcome Measures

Primary Outcomes (1)

  • Plasma isoprostanes/isofurans (mechanistic outcome)

    0 and 6 hours post-ROSC

Secondary Outcomes (1)

  • Modified Rankin Scale (mRS) (primary neurological outcome)

    hospital discharge

Other Outcomes (1)

  • Cognitive testing (primary neuropsychological outcome)

    180 days

Study Arms (1)

Adult patients resuscitated from cardiac arrest

Eligibility Criteria

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

Adult patients resuscitated from cardiac arrest

You may qualify if:

  • Age \>17 years
  • Cardiac arrest
  • Return of spontaneous circulation
  • Not following commands immediately after ROSC
  • Endotracheal intubation
  • Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)

You may not qualify if:

  • Presumed etiology of arrest is trauma
  • Presumed etiology of arrest is hemorrhage
  • Presumed etiology of arrest is sepsis
  • Permanent resident of nursing home or other long-term care facility
  • Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Indiana University/ Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This research will measure biomarkers of oxidative stress (isoprostanes and isofurans) on plasma samples.

MeSH Terms

Conditions

Heart ArrestHyperoxiaReperfusion Injury

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesPostoperative ComplicationsPathologic Processes

Study Officials

  • Stephen Trzeciak, MD, MPH

    The Cooper Health System

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations