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

September 22, 2015 updated by: RWTH Aachen University
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Surgical Intensive Care - Adults, University Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Michael Fries, PD Dr. med., Surgical Intensive Care - Adults, University Hospital Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xenon-MTH-Study
  • 2010-022679-71 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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