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

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ClinicalTrials.gov Identifier: NCT01262729
Recruitment Status : Terminated (Feasibility and Recruitment problems)
First Posted : December 17, 2010
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
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

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
Study Start Date : September 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR Hypothermia
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Significant difference between treatment group and control group [ Time Frame: within 28 days after cardiac arrest ]

Secondary Outcome Measures :
  1. Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation [ Time Frame: within 28 days after cardiac arrest ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262729


Locations
Germany
Surgical Intensive Care - Adults, University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Fries, PD Dr. med. Surgical Intensive Care - Adults, University Hospital Aachen

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 ( EudraCT Number )
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Respiratory Aspiration
Hypothermia
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