Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

NCT ID: NCT01262729

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xenon-Arm

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

Group Type EXPERIMENTAL

therapeutical hypothermia

Intervention Type PROCEDURE

Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)

Xenon Inhalation

Intervention Type DRUG

Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia

MTH

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

Group Type ACTIVE_COMPARATOR

therapeutical hypothermia

Intervention Type PROCEDURE

Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)

Interventions

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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)

Intervention Type PROCEDURE

Xenon Inhalation

Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Fries, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Surgical Intensive Care - Adults, University Hospital Aachen

Locations

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Surgical Intensive Care - Adults, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22425822 (View on PubMed)

Other Identifiers

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2010-022679-71

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Xenon-MTH-Study

Identifier Type: -

Identifier Source: org_study_id

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