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

RWTH Aachen University

Status and phase

Terminated

Phase 2

Conditions

Successful Cardiopulmonary Resuscitation

Addition to Therapeutical Hypothermia

Efficacy and Safety of Xenon Inhalation

Treatments

Procedure: therapeutical hypothermia

Drug: Xenon Inhalation

Study type

Interventional

Funder types

Other

Identifiers

NCT01262729

Xenon-MTH-Study

2010-022679-71 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Xenon-Arm

Experimental group

Description:

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

Treatment:

Drug: Xenon Inhalation

Procedure: therapeutical hypothermia

MTH

Active Comparator group

Description:

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

Treatment:

Procedure: therapeutical hypothermia