Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Phase 2

Terminated

• Conditions: Efficacy and Safety of Xenon Inhalation; Addition to Therapeutical Hypothermia; Successful Cardiopulmonary Resuscitation
• Interventions: Procedure: therapeutical hypothermia; Drug: Xenon Inhalation

• Registration Number: NCT01262729
• Lead Sponsor: RWTH Aachen University

Brief Summary

In this clinical trial will be checked, whether 2 hour ventilation with xenon has neuroprotective effects in patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation

Detailed Description

Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation will be randomized in two groups. First group (Treatment group) will be inhalated with xenon within 2 hours in addition to therapeutical hypothermia. The second group (Control group) will be treated with therapeutical hypothermia in accordance to international guidelines.

Study Timeline

• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Study Start: 2011-09
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation, which will be treated at Department of Internal Medicine I, University Hospital Aachen

Exclusion Criteria

• Patients younger than 18 years
• Xenon allergy
• Pregnancy
• High expired oxygen requirement (>70%) in order to maintain adequate arterial oxygen saturation (SpO2>94%) at the beginning of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenon-Arm	Xenon Inhalation	Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation.
MTH	therapeutical hypothermia	Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia
Xenon-Arm	therapeutical hypothermia	Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation.

Primary Outcome Measures

Name	Time	Method
Significant difference between treatment group and control group	within 28 days after cardiac arrest

Secondary Outcome Measures

Name	Time	Method
Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation	within 28 days after cardiac arrest

Trial Locations

Locations (1)

Surgical Intensive Care - Adults, University Hospital Aachen; 🇩🇪 Aachen, NRW, Germany