Skip to main content
OpenTrials
Completed

NCT Number: NCT00391469

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid infusion of 2 liters of 4oC normal saline

Other

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 names: Rapid infusion of cold normal saline

Rapid infusion of cold normal saline

Drug

Primary outcomes

  1. Number Alive at Hospital Discharge

    Time frame: at hospital discharge

Secondary outcomes

  1. Neurologic Status at Discharge-full Recovery

    Time frame: at time of discharge

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2006
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.