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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medic One Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Francis Kim, University of Washington
ClinicalTrials.gov Identifier:
NCT00391469
First received: October 20, 2006
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • awake and able to follow commands at hospital discharge [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • days to awakening, days to death, neurologic outcome [ Time Frame: at time of discharge, at 3 months following discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 1364
Study Start Date: December 2007
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 saline
Drug: Rapid infusion of cold normal saline

Detailed Description:

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391469

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Medic One Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Francis Kim, MD University of Washington
Study Director: Leonard Cobb, MD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Francis Kim, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00391469     History of Changes
Other Study ID Numbers: 29121-B, R01HL089554
Study First Received: October 20, 2006
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
cardiac arrest
mild hypothermia

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Out-of-Hospital Cardiac Arrest
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013