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

Primary Purpose

Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation, Addition to Therapeutical Hypothermia

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
therapeutical hypothermia
Xenon Inhalation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy and Safety of Xenon Inhalation focused on measuring xenon inhalation, therapeutical hypothermia, patients after cardiopulmonary resuscitation, efficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Surgical Intensive Care - Adults, University Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xenon-Arm

MTH

Arm Description

Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation.

Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia

Outcomes

Primary Outcome Measures

Significant difference between treatment group and control group

Secondary Outcome Measures

Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation

Full Information

First Posted
December 16, 2010
Last Updated
September 22, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01262729
Brief Title
Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
Acronym
10-015
Official Title
Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Feasibility and Recruitment problems
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation, Addition to Therapeutical Hypothermia
Keywords
xenon inhalation, therapeutical hypothermia, patients after cardiopulmonary resuscitation, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenon-Arm
Arm Type
Experimental
Arm Description
Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation.
Arm Title
MTH
Arm Type
Active Comparator
Arm Description
Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia
Intervention Type
Procedure
Intervention Name(s)
therapeutical hypothermia
Intervention Description
Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)
Intervention Type
Drug
Intervention Name(s)
Xenon Inhalation
Intervention Description
Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia
Primary Outcome Measure Information:
Title
Significant difference between treatment group and control group
Time Frame
within 28 days after cardiac arrest
Secondary Outcome Measure Information:
Title
Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation
Time Frame
within 28 days after cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fries, PD Dr. med.
Organizational Affiliation
Surgical Intensive Care - Adults, University Hospital Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Intensive Care - Adults, University Hospital Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22425822
Citation
Fries M, Brucken A, Cizen A, Westerkamp M, Lower C, Deike-Glindemann J, Schnorrenberger NK, Rex S, Coburn M, Nolte KW, Weis J, Rossaint R, Derwall M. Combining xenon and mild therapeutic hypothermia preserves neurological function after prolonged cardiac arrest in pigs. Crit Care Med. 2012 Apr;40(4):1297-303. doi: 10.1097/CCM.0b013e31823c8ce7.
Results Reference
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Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

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