Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329563
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2006-05-22
Brief Title:
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field In this pilot study we will randomize 125 patients after return of spontaneous circulation ROSC to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes IV sedation and muscle paralysis or to standard of care following ROSC The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy The primary outcome measures will include temperature changes of the patients at time of admission to the hospital Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None