Effect of Xenon and Therapeutic Hypothermia, on the Brain and on Neurological Outcome Following Brain Ischemia in Cardiac Arrest Patients

Completed · Phase 2

Conditions studied: Ischemic Brain Injury

In brief

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 interaction of xenon and hypothermia in patients suffering cerebral ischemia post cardiac arrest, by undertaking brain imaging to evaluate their effects on cerebral hypoxia, neuronal loss and mitochondrial dysfunction. In addition, the investigators aim to correlate these findings with neurological outcome to determine surrogate markers of favourable clinical outcome at six months.

Key facts

Study ID

NCT00879892

Run by

Turku University Hospital

People needed

110

Starts

2009-05-01

Expected to finish

2014-09-01

Last updated by the study team

2015-01-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Anesthesia and Perioperative Care — San Francisco, California, United States
• Department of Neurology, Meilahti, Helsinki University Hospital — Helsinki, Finland
• Department of Radiology, HUSRontgen, Meilahti, Helsinki University Hospital — Helsinki, Finland
• Intensive Care Unit, Meilahti, Helsinki University Hospital — Helsinki, Finland
• Department of Cardiology, Meilahti, Helsinki University Hospital — Helsinki, Finland
• Adult Intensive Care Unit, Turku University Hospital — Turku, Finland
• Department of Internal Medicine, Division of Cardiology, Turku University Hospital — Turku, Finland
• Department of Neurology; Turku University Hospital — Turku, Finland
• Department of Radiology, Turku University Hospital — Turku, Finland
• PET Centre — Turku, Finland

Full record on ClinicalTrials.gov

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