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 resuscitationMedDRA version: 16.1Level: PTClassification code 10067221Term: Mechanical ventilationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic 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
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
- 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
Name Time Method 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
Name Time Method 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