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TerminatedNCT0126272910-015Updated Sep 23, 2015

Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

A Phase 2 interventional study of therapeutical hypothermia and Xenon Inhalation in Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation and Addition to Therapeutical Hypothermia, sponsored by RWTH Aachen University. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by RWTH Aachen University · Phase 2, Interventional, and Treatment

Why this study was terminated
Feasibility and Recruitment problems
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

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

Keywords

  • xenon inhalation
  • therapeutical hypothermia
  • patients after cardiopulmonary resuscitation
  • efficacy
  • safety
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 5 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • 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 · Drug: Xenon Inhalation

  • Active comparator
    MTH

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

    Procedure: therapeutical hypothermia

Interventions

  • Proceduretherapeutical hypothermia

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

  • DrugXenon Inhalation

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

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What researchers measure

Primary outcomes

  1. Significant difference between treatment group and control group

    Time frame: within 28 days after cardiac arrest

Secondary outcomes

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

    Time frame: within 28 days after cardiac arrest

07

Study locations

1 site
  • Surgical Intensive Care - Adults, University Hospital Aachen
    Aachen, NRW 52074, Germany
08

References and documents

Publications

  • 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. PubMed 22425822 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01262729
Lead sponsor
RWTH Aachen University
Responsible party
Sponsor
First posted
Dec 17, 2010
Start date
Sep 2011
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Sep 23, 2015

Study contacts

Michael Fries, PD Dr. med.
principal investigator · Surgical Intensive Care - Adults, University Hospital Aachen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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