Phase 3
N=1,359
Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT00391469 ↗Enrolled (actual)
1,359
Serious AEs
78.0%
Results posted
Dec 2014
Primary outcome: Primary: Number Alive at Hospital Discharge — 187; 183; 62; 76 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rapid infusion of 2 liters of 4oC normal saline (Other); Rapid infusion of cold normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Alive at Hospital Discharge |
187; 183; 62; 76 | — |
| SECONDARY Neurologic Status at Discharge-full Recovery |
145; 125; 34; 36 | — |
Summary
The overall goal of this study is to determine whether initiating hypothermia in cardiac arrest patients as soon as possible in the field results in a greater proportion of patients who survive to hospital discharge compared to standard prehospital/field care.
Eligibility Criteria
Inclusion Criteria
- successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse
Exclusion Criteria
- traumatic cause for cardiac arrest
Data sourced from ClinicalTrials.gov (NCT00391469). 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.