N/A N=542 Randomized Treatment

A Pilot Study of Intra-arrest Therapeutic Hypothermia in Patients Suffering Non-Traumatic Out of Hospital Cardiac Arrest

Out-of-Hospital Cardiac Arrest

Bottom Line

View on ClinicalTrials.gov: NCT01413399 ↗

Enrolled (actual)

542

Serious AEs

0.0%

Results posted

Dec 2021

Primary outcome: Primary: Number of Participants Who Survived Up To Hospital Discharge — 24; 40 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 4 degree chilled saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Survived Up To Hospital Discharge	24; 40	—
SECONDARY Number of Patients Who Achieve Prehospital Return of Spontaneous Circulation	76; 90	—

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).

Eligibility Criteria

Inclusion Criteria

Cardiac arrest of presumed medical etiology in the out-of-hospital setting

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01413399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.