Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
|Out-of-hospital Cardiac Arrest||Other: Rapid infusion of 2 liters of 4oC normal saline Drug: Rapid infusion of cold normal saline||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of the Use of Mild Hypothermia in Out-of-hospital Cardiac Arrest Using a Rapid Infusion of 2 Liters of Cold Normal Saline|
- Number Alive at Hospital Discharge [ Time Frame: at hospital discharge ]
- Neurologic Status at Discharge-full Recovery [ Time Frame: at time of discharge ]
|Study Start Date:||December 2007|
|Study Completion Date:||August 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|No Intervention: control treatment||
Other: Rapid infusion of 2 liters of 4oC normal saline
Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.
Other Name: Rapid infusion of cold normal salineDrug: Rapid infusion of cold normal saline
In this study we will randomize 1,200 cardiac arrest patients who have 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 objective of this study will be to determine whether induction of mild hypothermia using an infusion of cold normal saline will improve the proportion of patients who survive and are discharged awake from the hospital.
Hypothesis: In cardiac arrest patients who achieve ROSC in the field, initiation of hypothermia by infusion of cold normal saline will result in a greater proportion of cardiac arrest patients discharged awake from the hospital compared to standard care.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391469
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Francis Kim, MD||University of Washington|
|Study Director:||Leonard Cobb, MD||University of Washington|