Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Addition to Therapeutical Hypothermia Clinical Trial

— 10-015  

Official title:

Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01262729
• Other study ID #: Xenon-MTH-Study
• Secondary ID: 2010-022679-71
• Status: Terminated
• Phase: Phase 2
• First received: December 16, 2010
• Last updated: September 22, 2015
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addition to Therapeutical Hypothermia
• Efficacy and Safety of Xenon Inhalation
• Hypothermia
• Respiratory Aspiration
• Successful Cardiopulmonary Resuscitation

Intervention

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

Locations

Country	Name	City	State
Germany	Surgical Intensive Care - Adults, University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant difference between treatment group and control group		within 28 days after cardiac arrest	Yes
Secondary	Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation		within 28 days after cardiac arrest	Yes