ClinicalTrials.Veeva

Menu

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

University of Washington logo

University of Washington

Status and phase

Completed
Phase 3
Phase 2

Conditions

Out-of-hospital Cardiac Arrest

Treatments

Drug: Rapid infusion of cold normal saline
Other: Rapid infusion of 2 liters of 4oC normal saline

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00391469
R01HL089554 (U.S. NIH Grant/Contract)
29121-B

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,359 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,359 participants in 1 patient group

control treatment
No Intervention group
Treatment:
Other: Rapid infusion of 2 liters of 4oC normal saline
Drug: Rapid infusion of cold normal saline

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems