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

Primary Purpose

Out-of-hospital Cardiac Arrest

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rapid infusion of 2 liters of 4oC normal saline

Rapid infusion of cold normal saline

About this trial

This is an interventional treatment trial for Out-of-hospital Cardiac Arrest focused on measuring cardiac arrest, mild hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Harborview Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

control treatment

Arm Description

Outcomes

Primary Outcome Measures

Number Alive at Hospital Discharge

Secondary Outcome Measures

Neurologic Status at Discharge-full Recovery

Full Information

NCT ID

NCT00391469

First Posted

October 20, 2006

Last Updated

November 23, 2014

Sponsor

University of Washington

Collaborators

Medic One Foundation, National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT00391469

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Medic One Foundation, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Out-of-hospital Cardiac Arrest

Keywords

cardiac arrest, mild hypothermia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1359 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control treatment

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Rapid infusion of 2 liters of 4oC normal saline

Other Intervention Name(s)

Rapid infusion of cold normal saline

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Rapid infusion of cold normal saline

Primary Outcome Measure Information:

Title

Number Alive at Hospital Discharge

Time Frame

at hospital discharge

Secondary Outcome Measure Information:

Title

Neurologic Status at Discharge-full Recovery

Time Frame

at time of discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis Kim, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leonard Cobb, MD

Organizational Affiliation

University of Washington

Official's Role

Study Director

Facility Information:

Facility Name

Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25762805

Citation

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.

Results Reference

derived

PubMed Identifier

24240712

Citation

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.

Results Reference

derived

PubMed Identifier

24188226

Citation

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.

Results Reference

derived

PubMed Identifier

17823147

Citation

Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60. doi: 10.1136/bmj.39315.519201.BE.

Results Reference

derived

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

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