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

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

Study Description

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 Design

• 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
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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

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

Maynard C, Longstreth WT Jr, Nichol G, Hallstrom A, Kudenchuk PJ, Rea T, Copass MK, Carlbom D, Deem S, Olsufka M, Cobb LA, Kim F. Effect of prehospital induction of mild hypothermia on 3-month neurological status and 1-year survival among adults with cardiac arrest: long-term follow-up of a randomized, clinical trial. J Am Heart Assoc. 2015 Mar 11;4(3):e001693. doi: 10.1161/JAHA.114.001693.

Kim F, Nichol G, Maynard C, Hallstrom A, Kudenchuk PJ, Rea T, Copass MK, Carlbom D, Deem S, Longstreth WT Jr, Olsufka M, Cobb LA. Effect of prehospital induction of mild hypothermia on survival and neurological status among adults with cardiac arrest: a randomized clinical trial. JAMA. 2014 Jan 1;311(1):45-52. doi: 10.1001/jama.2013.282173.

Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010. Review.

Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60.

• Responsible Party: Francis Kim, Study Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT00391469
• Other Study ID Numbers: 29121-B; R01HL089554 ( U.S. NIH Grant/Contract )
• First Posted: October 24, 2006
• 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; Out-of-Hospital Cardiac Arrest; Hypothermia; Heart Diseases; Cardiovascular Diseases; Body Temperature Changes