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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Collaborators: Academy of Finland; Academy of Finland (Risto O Roine); University of Turku
• Treatments: Xenon

Criteria

Inclusion Criteria:

1. Ventricular fibrillation or non-perfusive ventricular tachycardia as initial cardiac rhythm

2. The 1st attempt at resuscitation by emergency medical personnel must appear within 15 minutes after the collapse

3. 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

4. Patient should be still unconscious in the emergency room

5. Age: 18 - 80 years

6. Obtained consent within 4 hours after arrival to the hospital

Exclusion criteria

1. Hypothermia (< 30°C core temperature)

2. Unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhages, intoxications etc.)

3. Response to verbal commands after the return of spontaneous circulation and before randomization

4. Pregnancy

5. Coagulopathy

6. Terminal phase of a chronic disease

7. Systolic arterial pressure < 80 mmHg or mean arterial pressure < 60 mmHg for over 30 min period after ROSC

8. Evidence of hypoxemia (arterial oxygen saturation < 85%) for > 15 minutes after ROSC and before randomization.

9. Factors making participation in follow-up unlikely

10. Enrolment in another study