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Xenon and Therapeutical Hypothermia After Successful CardiopulmonaryResuscitatio

Conditions
In this clinical trial will be checked, whether 2 hours ventilation with xenon has neuroprotetctive effect on the patients, which had out of hospital cardiac arrest and successful cardiopulmonary resuscitation
MedDRA version: 16.1Level: PTClassification code 10067221Term: Mechanical ventilationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2010-022679-71-DE
Lead Sponsor
Clinical Trials Center Aachen, University of Aachen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patients with out of hospital cardiac arrest and successeful cardiopulmonary resuscitation, which will be treated with therapeutic hypothermia at Department of Internal Medicine I of Teaching Hospital of Unversity of Aachen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Feasibility and safety of combined treatment of xenon and therapeutic hypothermia in patients with successfull cardiopulmonary resuscitation after out of hospital cardiac arrest ;Secondary Objective: Influence of combined treatment of xenon and therapeutic hypothermia on neurological outcome , cardiac function and mortality in patients with successfull cardiopulmonary resuscitation after out of hospital cardiac arrest ;Primary end point(s): Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonale resuscitation;Timepoint(s) of evaluation of this end point: during 2h of Xenon-Ventilation
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): Significant difference between treatment group and control group.;Timepoint(s) of evaluation of this end point: within 28 days after cardiac arrest
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