A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest
1 other identifier
interventional
542
1 country
1
Brief Summary
The objective of this study will be to assess the frequency of return of spontaneous circulation (ROSC), survival to admission, survival to discharge from the hospital, and neurologic function at time of discharge from the hospital among patients experiencing out of hospital cardiac arrest randomized to receive either intra-arrest induction of therapeutic hypothermia (IATH) or post-arrest therapeutic hypothermia (TH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
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
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
December 8, 2021
CompletedJune 28, 2022
November 1, 2021
10 months
August 9, 2011
November 9, 2021
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Survived Up To Hospital Discharge
Adjusted OR and 95% CI
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary Outcomes (1)
Number of Patients Who Achieve Prehospital Return of Spontaneous Circulation
Patients will be followed for the duration of their prehospital course of care expected to be an average of 1 hour
Study Arms (2)
Intra-Arrest Therapeutic Hypothermia
ACTIVE COMPARATORPost-Arrest Therapeutic Hypothermia
ACTIVE COMPARATORInterventions
4 degree chilled saline up to 2L in the prehospital setting
Eligibility Criteria
You may qualify if:
- Cardiac arrest of presumed medical etiology in the out-of-hospital setting
You may not qualify if:
- Traumatic Cardiac Arrests
- Cardiac Arrests Due to hemorrhage
- Cardiac arrests involving children or young adults
- Patients presumed to be pregnant
- Patients with a do not resuscitate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolinas Medical Center; Center for Prehospital MEdicine
Charlotte, North Carolina, 28232, United States
Related Publications (1)
Garrett JS, Studnek JR, Blackwell T, Vandeventer S, Pearson DA, Heffner AC, Reades R. The association between intra-arrest therapeutic hypothermia and return of spontaneous circulation among individuals experiencing out of hospital cardiac arrest. Resuscitation. 2011 Jan;82(1):21-5. doi: 10.1016/j.resuscitation.2010.09.473. Epub 2010 Oct 30.
PMID: 21036449BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan R Studnek PhD
- Organization
- Mecklenburg EMS Agency
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan R Studnek, PhD
Carolinas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 10, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 28, 2022
Results First Posted
December 8, 2021
Record last verified: 2021-11