NCT00282373

Brief Summary

The primary objectives of this study are to determine the safety and feasibility of inducing mild hypothermia using a non-invasive thermoregulatory device, the Medivance Arctic Sun Temperature Management System, in patients resuscitated after cardiac arrest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2004

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

November 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 11, 2007

Status Verified

September 1, 2007

First QC Date

January 24, 2006

Last Update Submit

September 10, 2007

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (3)

  • Feasibility -patient temperature below 34C within 4 hours

  • Feasibility -maintain patient target temperature for 24 hrs

  • Safety - serious adverse events, mortality

Secondary Outcomes (1)

  • Effectiveness - neurological outcome measured by OPC/CPC

Interventions

mild hypothermiaDEVICE

Eligibility Criteria

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

You may qualify if:

  • Male or female patients ≥ 18 years.
  • Witnessed out-of-hospital cardiac arrest of presumed cardiac origin in which the initial rhythm is ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA) or asystole.
  • First attempt at resuscitation (ACLS or CPR) by emergency medical personnel initiated within 15 minutes of collapse.
  • Restoration of spontaneous circulation (ROSC) within 60 minutes of collapse.
  • Time from restoration of spontaneous circulation to initiation of cooling is ≤ 6 hours.
  • Informed consent provided by authorized representative/family member.

You may not qualify if:

  • Temperature of less than 35C on admission.
  • Comatose or vegetative state prior to cardiac arrest.
  • Positive pregnancy test.
  • Purposeful response to verbal commands after ROSC and prior to initiation of hypothermia.
  • Evidence of hypotension (MAP\<60) for more than 30 minutes after ROSC and prior to initiation of hypothermia.
  • Evidence of hypoxia (oxygen saturation\<85% despite supplemental oxygen) for more than 15 minutes after ROSC and prior to initiation of hypothermia.
  • Terminal illness that preceded the arrest (life expenctancy \< 1 year).
  • Patients experiencing cardiogenic shock.
  • Patients continuing to experience refractory ventricular arrhythmias at the time of enrollment.
  • Patients receiving 2 or more high dose vasopressors.
  • Active bleeding or known preexisting coagulapathy.
  • Patient history of cold agglutinin disease.
  • Patient history of Raynaud's Disease.
  • Patient history of Sickle Cell disease.
  • Evidence of compromised skin integrity or irregularities (such as urticaria, rash, lacerations, burns, abrasions.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

University of Colorado Health Science Center

Denver, Colorado, 80262, United States

Location

Johns Hopkins - Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Heard KJ, Peberdy MA, Sayre MR, Sanders A, Geocadin RG, Dixon SR, Larabee TM, Hiller K, Fiorello A, Paradis NA, O'Neil BJ. A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest. Resuscitation. 2010 Jan;81(1):9-14. doi: 10.1016/j.resuscitation.2009.09.015. Epub 2009 Oct 24.

    PMID: 19854555DERIVED

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Kennon Heard, M.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 26, 2006

Study Start

November 1, 2004

Study Completion

September 1, 2007

Last Updated

September 11, 2007

Record last verified: 2007-09

Locations

US(6)