Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
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|ClinicalTrials.gov Identifier: NCT00391469|
Recruitment Status : Completed
First Posted : October 24, 2006
Results First Posted : December 2, 2014
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1359 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2013|
|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
- Number Alive at Hospital Discharge [ Time Frame: at hospital discharge ]
- Neurologic Status at Discharge-full Recovery [ Time Frame: at time of discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|