Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation (10-015)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01262729
First received: December 16, 2010
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Efficacy and Safety of Xenon Inhalation
Successful Cardiopulmonary Resuscitation
Addition to Therapeutical Hypothermia
Procedure: therapeutical hypothermia
Drug: Xenon Inhalation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Significant difference between treatment group and control group [ Time Frame: within 28 days after cardiac arrest ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation [ Time Frame: within 28 days after cardiac arrest ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenon-Arm
Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation.
Procedure: therapeutical hypothermia
Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)
Drug: Xenon Inhalation
Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia
Active Comparator: MTH
Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia
Procedure: therapeutical hypothermia
Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262729

Contacts
Contact: Michael Fries, PD Dr. med. + 49 241 80 ext 80444 mfries@ukaachen.de
Contact: Margarita Gritzewski, M.Sc. + 49 241 80 ext 35664 mgritzewski@ukaachen.de

Locations
Germany
Surgical Intensive Care - Adults, University Hospital Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Michael Fries, PD Dr. med.    +49 241 80 ext 80444    mfries@ukaachen.de   
Contact: Margarita Gritzewski, M.Sc.    + 49 241 80 ext 35664    mgritzewski@ukaachen.de   
Principal Investigator: Michael Freis, PD Dr. med.         
Sub-Investigator: Jörg Schröder, Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Fries, PD Dr. med. Surgical Intensive Care - Adults, University Hospital Aachen
  More Information

No publications provided by RWTH Aachen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01262729     History of Changes
Other Study ID Numbers: Xenon-MTH-Study, 2010-022679-71
Study First Received: December 16, 2010
Last Updated: April 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
xenon inhalation
therapeutical hypothermia
patients after cardiopulmonary resuscitation
efficacy
safety

Additional relevant MeSH terms:
Hypothermia
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014