Clinical trial NCT00391469: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Out-of-hospital Cardiac Arrest
Keywords: cardiac arrest
mild hypothermia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Medic One Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-10-24
Enrollment: 1359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number Alive at Hospital Discharge
timeFrame: at hospital discharge
Secondary outcomes:
measure: Neurologic Status at Discharge-full Recovery
timeFrame: at time of discharge
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Francis Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Leonard Cobb, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.