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

Out-of-hospital Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391469
• Other study ID #: 29121-B
• Secondary ID: R01HL089554
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 20, 2006
• Last updated: November 23, 2014
• Start date: December 2007
• Est. completion date: August 2013

Study information

• Verified date: November 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1359
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Drug:
• Rapid infusion of cold normal saline

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Medic One Foundation, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Alive at Hospital Discharge		at hospital discharge	No
Secondary	Neurologic Status at Discharge-full Recovery		at time of discharge	No