NCT00391469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,359

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 2, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

5.4 years

First QC Date

October 20, 2006

Results QC Date

November 23, 2014

Last Update Submit

November 23, 2014

Conditions

Out-of-hospital Cardiac Arrest

Keywords

cardiac arrestmild hypothermia

Outcome Measures

Primary Outcomes (1)

  • Number Alive at Hospital Discharge

    at hospital discharge

Secondary Outcomes (1)

  • Neurologic Status at Discharge-full Recovery

    at time of discharge

Study Arms (1)

control treatment

NO INTERVENTION
Other: Rapid infusion of 2 liters of 4oC normal salineDrug: Rapid infusion of cold normal saline

Interventions

Rapid infusion of 2 liters of 4oC normal salineOTHER

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.

Also known as: Rapid infusion of cold normal saline
control treatment
Rapid infusion of cold normal salineDRUG
control treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • successful resuscitation from out-of-hospital cardiac arrest by paramedics, defined by having a palpable pulse

You may not qualify if:

  • traumatic cause for cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (4)

  • 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.

    PMID: 25762805DERIVED

  • 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.

    PMID: 24240712DERIVED

  • 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.

    PMID: 24188226DERIVED

  • 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.

    PMID: 17823147DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Francis Kim, MD Associate Professor of Medicine
Organization
University of Washington
fkim@u.washington.edu
206-744-8712

Study Officials

  • Francis Kim, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Leonard Cobb, MD

    University of Washington

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

December 1, 2007

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

December 2, 2014

Results First Posted

December 2, 2014

Record last verified: 2014-11

Locations

US(1)