Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients
Completed · Phase 2/Phase 3
Conditions studied: Cardiac Arrest
In brief
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.
Key facts
- Study ID
- NCT00282373
- Run by
- Medivance, Inc.
- People needed
- 64
- Starts
- 2004-11-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2007-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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 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.
Where it is running
- University of Arizona Medical Center — Tucson, Arizona, United States
- University of Colorado Health Science Center — Denver, Colorado, United States
- Johns Hopkins - Bayview Medical Center — Baltimore, Maryland, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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