Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest

This study has been completed.
Sponsor:
Collaborators:
Medic One Foundation
Information provided by (Responsible Party):
Francis Kim, University of Washington
ClinicalTrials.gov Identifier:
NCT00391469
First received: October 20, 2006
Last updated: October 31, 2013
Last verified: October 2013

October 20, 2006
October 31, 2013
December 2007
May 2013   (final data collection date for primary outcome measure)
Survival and awake and able to follow commands at hospital discharge [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]
survival at hospital discharge
Complete list of historical versions of study NCT00391469 on ClinicalTrials.gov Archive Site
days to awakening, days to death, neurologic outcome [ Time Frame: at time of discharge, at 3 months following discharge ] [ Designated as safety issue: No ]
days to awakening, days to death, neurologic outcome
Not Provided
Not Provided
 
Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
Study of the Use of Mild Hypothermia in Out-of-hospital Cardiac Arrest Using a Rapid Infusion of 2 Liters of Cold Normal Saline

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Out-of-hospital Cardiac Arrest
  • 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 saline
  • Drug: Rapid infusion of cold normal saline
No Intervention: control treatment
Interventions:
  • Other: Rapid infusion of 2 liters of 4oC normal saline
  • Drug: Rapid infusion of cold normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1359
August 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00391469
29121-B, R01HL089554
Yes
Francis Kim, University of Washington
University of Washington
  • Medic One Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Francis Kim, MD University of Washington
Study Director: Leonard Cobb, MD University of Washington
University of Washington
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP