Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Conditions
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Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation, Addition to Therapeutical Hypothermia

Intervention / Treatment
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* Procedure: therapeutical hypothermia
* Drug: Xenon Inhalation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xenon-Arm<br>Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation. | Procedure: therapeutical hypothermia<br>* Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)<br>Drug: Xenon Inhalation<br>* Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia<br>|
| Active Comparator: MTH<br>Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia | Procedure: therapeutical hypothermia<br>* Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant difference between treatment group and control group |  | within 28 days after cardiac arrest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation |  | within 28 days after cardiac arrest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xenon inhalation, therapeutical hypothermia, patients after cardiopulmonary resuscitation, efficacy, safety