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: November 23, 2014
Last verified: November 2014
Results First Received: November 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Out-of-hospital Cardiac Arrest
Interventions: Other: Rapid infusion of 2 liters of 4oC normal saline
Drug: Rapid infusion of cold normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention

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.

Rapid infusion of cold normal saline

Control standard of care

Participant Flow:   Overall Study
    Intervention     Control  
STARTED     688     671  
COMPLETED     688 [1]   671  
NOT COMPLETED     0     0  
[1] 5 patients were found to be incarcerated at time of randomization, thus data was not included



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
VF-randomized to Standard Treatment standard treatment following VF cardiac arrest
VF-randomized to Hypothermia

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.

Rapid infusion of cold normal saline

Non-VF Randomized to Standard Treatment standard treatment following non-VF cardiac arrest
Non-VF-randomized to Hypothermia

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.

Rapid infusion of cold normal saline

Total Total of all reporting groups

Baseline Measures
    VF-randomized to Standard Treatment     VF-randomized to Hypothermia     Non-VF Randomized to Standard Treatment     Non-VF-randomized to Hypothermia     Total  
Number of Participants  
[units: participants]
  291     292     380     396     1359  
Age  
[units: years]
Mean (Standard Deviation)
  62.1  (15.6)     62.1  (14.2)     67.5  (16.5)     68.3  (16.3)     65.1  (15.3)  
Gender  
[units: participants]
         
Female     74     65     175     180     494  
Male     217     227     205     216     865  
Region of Enrollment  
[units: participants]
         
United States     291     292     380     396     1359  



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Francis Kim, MD Associate Professor of Medicine
Organization: University of Washington
phone: 206-744-8712
e-mail: fkim@u.washington.edu


No publications provided by University of Washington

Publications automatically indexed to this study:

Responsible Party: Francis Kim, University of Washington
ClinicalTrials.gov Identifier: NCT00391469     History of Changes
Other Study ID Numbers: 29121-B, R01HL089554
Study First Received: October 20, 2006
Results First Received: November 23, 2014
Last Updated: November 23, 2014
Health Authority: United States: Food and Drug Administration