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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
Sponsor:
Collaborators:
Medic One Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Francis Kim, University of Washington

Brief Summary:
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 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

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 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Primary Completion Date : May 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number Alive at Hospital Discharge [ Time Frame: at hospital discharge ]

Secondary Outcome Measures :
  1. Neurologic Status at Discharge-full Recovery [ Time Frame: at time of discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

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 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2006    Key Record Dates
Results First Posted: December 2, 2014
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Francis Kim, 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