Status:
COMPLETED
Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients
Lead Sponsor:
Medivance, Inc.
Conditions:
Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 Managem...
Detailed Description
Extensive research has been conducted in the use of mild hypothermia as a neuroprotectant in acute brain injury in animal models with studies having been initiated as far back as the 1950's. However, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Temperature of less than 35C 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.
- Patient weight \> 114 kg (250 lbs) or \< 50 kg (110 lbs)
- Enrollment in another therapeutic study.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00282373
Start Date
November 1 2004
End Date
September 1 2007
Last Update
September 11 2007
Active Locations (6)
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1
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
2
University of Colorado Health Science Center
Denver, Colorado, United States, 80262
3
Johns Hopkins - Bayview Medical Center
Baltimore, Maryland, United States, 21224
4
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073