Efficacy and Safety of Xenon InhalationPhase 210-015NCT01262729
Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
A Phase 2 study testing therapeutical hypothermia and Xenon Inhalation in people with Efficacy and Safety of Xenon Inhalation and Successful Cardiopulmonary Resuscitation, run by RWTH Aachen University at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation, Addition to Therapeutical Hypothermia
- What is being tested?
- therapeutical hypothermia and Xenon Inhalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation, which will be treated at Department of Internal Medicine I, University Hospital Aachen
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Surgical Intensive Care - Adults, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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.
- Conditions
- Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation, Addition to Therapeutical Hypothermia
- Being tested
- therapeutical hypothermia, Xenon Inhalation
- Keywords
- xenon inhalation, therapeutical hypothermia, patients after cardiopulmonary resuscitation, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutical hypothermiaProcedure or surgery
Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)
Xenon InhalationDrug
Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Xenon-Arm | Experimental | Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation. Receives: Procedure: therapeutical hypothermia; Drug: Xenon Inhalation |
| MTH | Active comparator | Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia Receives: Procedure: therapeutical hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant difference between treatment group and control group
Measured: within 28 days after cardiac arrest
Secondary outcomes (1)
Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation
Measured: within 28 days after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startSep 2011
- Primary completionNov 2014
- Study completionDec 2014
Why it stopped: Feasibility and Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy and Safety of Xenon InhalationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Fries, PD Dr. med., Principal investigator, Surgical Intensive Care - Adults, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262729
- Sponsor's protocol ID
- Xenon-MTH-Study
- Other IDs
- 2010-022679-71
- Acronym
- 10-015
- Status last verified
- Sep 2015
- First submitted
- 16 Dec 2010
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT01262729
- Acronym / sponsor ID
- 10-015 / Xenon-MTH-Study
- Conditions
- Efficacy and Safety of Xenon Inhalation, Successful Cardiopulmonary Resuscitation, Addition to Therapeutical Hypothermia
- Keywords
- xenon inhalation, therapeutical hypothermia, patients after cardiopulmonary resuscitation, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility and Recruitment problems
- Enrolment
- 5 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon-Arm | Experimental | Procedure: therapeutical hypothermia, Drug: Xenon InhalationPatients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation. |
| MTH | Active comparator | Procedure: therapeutical hypothermiaPatients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation, which will be treated at Department of Internal Medicine I, University Hospital Aachen
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutical hypothermiaPatients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23) | Procedure or surgery | MTH, Xenon-Arm |
| Xenon InhalationPatients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia | Drug | Xenon-Arm |
Primary outcome
Significant difference between treatment group and control group
Time frame: within 28 days after cardiac arrest
1 secondary outcome
Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation
Time frame: within 28 days after cardiac arrest
Results and safety
The study was stopped early (reason given: Feasibility and Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Derived from this study: PubMed 22425822Fries 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fries, PD Dr. med. principal investigator
Surgical Intensive Care - Adults, University Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing therapeutical hypothermia and Xenon Inhalation in people with Efficacy and Safety of Xenon Inhalation and Successful Cardiopulmonary Resuscitation, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Feasibility and Recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant difference between treatment group and control group (time frame: within 28 days after cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.