Status:
COMPLETED
Effect of Xenon and Therapeutic Hypothermia, on the Brain and on Neurological Outcome Following Brain Ischemia in Cardiac Arrest Patients
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Academy of Finland
University of Turku
Conditions:
Ischemic Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to explore whether xenon is neuroprotective in humans. In addition, the purpose is to explore the underlying mechanisms for the possible synergistic neuroprotective i...
Detailed Description
If cardiac resuscitation is successful, the state-of-the-art management is to actively cool these patients into a state of moderate hypothermia (32-34º C) for 24 hours in an intensive care unit. Guide...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Ventricular fibrillation or non-perfusive ventricular tachycardia as initial cardiac rhythm
- The 1st attempt at resuscitation by emergency medical personnel must appear within 15 minutes after the collapse
- The cause for collapse should be considered primary as cardiogenic and the return of spontaneous circulation (ROSC) should have been gained in 45 minutes after the collapse
- Patient should be still unconscious in the emergency room
- Age: 18 - 80 years
- Obtained consent within 4 hours after arrival to the hospital
- Exclusion criteria
- Hypothermia (\< 30°C core temperature)
- Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhages, intoxications etc.)
- Response to verbal commands after the return of spontaneous circulation and before randomization
- Pregnancy
- Coagulopathy
- Terminal phase of a chronic disease
- Systolic arterial pressure \< 80 mmHg or mean arterial pressure \< 60 mmHg for over 30 min period after ROSC
- Evidence of hypoxemia (arterial oxygen saturation \< 85%) for \> 15 minutes after ROSC and before randomization.
- Factors making participation in follow-up unlikely
- Enrolment in another study
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00879892
Start Date
May 1 2009
End Date
September 1 2014
Last Update
January 19 2015
Active Locations (10)
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1
Department of Anesthesia and Perioperative Care
San Francisco, California, United States
2
Department of Neurology, Meilahti, Helsinki University Hospital
Helsinki, Finland, 340
3
Department of Radiology, HUSRontgen, Meilahti, Helsinki University Hospital
Helsinki, Finland, 340
4
Intensive Care Unit, Meilahti, Helsinki University Hospital
Helsinki, Finland, 340