XenonPhase 3CArDiAXNCT01285271
A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon
A Phase 3 study testing Xenon and Sevoflurane in people with Xenon and Sevoflurane, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Xenon, Sevoflurane, Anesthetics, Inhalation
- What is being tested?
- Xenon and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Sep 2011
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease scheduled for elective CABG
- Patients willing and able to complete the requirements of this study
- Ejection Fraction > 50%
- EuroSCORE ≤ 8
- men and women >= 50 yrs
- women without childbearing potential
- ASA Score II-IV
Who cannot join
- Lack of informed consent
- EuroSCORE < 8
- MMSE < 24
- Age < 50 years
- COPD GOLD > II, increased need of oxygen
- Renal dysfunction
Show all 18Show fewer
- Liver function disorders
- Acute coronary syndrome during the last 24 hours; hemodynamic instability
- Requirement of inotropic support
- Off-pump-surgery
- Disabling neuropsychiatric disorders
- History of stroke with residuals
- Hypersensitivity to the study anaesthetics
- Increased intracranial pressure
- Pregnancy and lactation period
- Women of childbearing potential
- Presumed uncooperativeness or legal incapacity
- Participation in a concomitant trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.
Read the detailed description
The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions.
Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.
- Being tested
- Xenon, Sevoflurane
- Keywords
- xenon, sevoflurane, cardiac anesthesia, CABG, Bypass surgery
- Medical subject headings
- Respiratory Aspiration, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
SevofluraneDrug
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Experimental | Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation. Receives: Drug: Xenon |
| Sevoflurane | Active comparator | Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation
The feasibility of xenon application compared to sevoflurane application will be assessed by:
- The depth of anaesthesia level
- The peri-anaesthetic respiratory profile
- The peri-anaesthetic haemodynamic profile
The following safety parameters will be assessed:
- Doses and concentration of study treatments
- Trans-esophageal echocardiography
- Measures of renal function
- Intra-operative blood loss and amount of transfused blood/products
- Need for hemodynamic and inotropic support
- The patient's regional cerebral tissue oxygenation rSO2
- The incidence of AE and SAE
Measured: an average of 4 to 6 hours
Secondary outcomes (2)
Secondary efficacy and safety criteria
The following secondary efficacy parameters will be assessed:
- the patients organ function status
- The severity of postoperative critical illness
- The incidence of Post-operative Delirium (POD)
- The duration of postoperative intensive care unit and in-hospital stay
Secondary safety parameters:
- hemodynamic and respiratory profile, including vital signs
- incidence of major adverse cardiac and cerebral events (MACCE)
- laboratory parameters -post-operative pain
- further AE and SAE
Measured: 6 days
all cause mortality and contentment questioning
Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for XenonStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Mark Coburn, PD Dr. med., Principal investigator, Department of Anesthesiology, University Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285271
- Sponsor's protocol ID
- 10-017
- Other IDs
- 2010-023942-63
- Acronym
- CArDiAX
- Status last verified
- Oct 2011
- First submitted
- 24 Jan 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Breuer T, Emontzpohl C, Coburn M, Benstoem C, Rossaint R, Marx G, Schalte G, Bernhagen J, Bruells CS, Goetzenich A, Stoppe C. Xenon triggers pro-inflammatory effects and suppresses the anti-inflammatory response compared to sevoflurane in patients undergoing cardiac surgery. Crit Care. 2015 Oct 15;19:365. doi: 10.1186/s13054-015-1082-7.
PubMed 26467531Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.
PubMed 23578862
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
- ClinicalTrials.gov ID
- NCT01285271
- Acronym / sponsor ID
- CArDiAX / 10-017
- Keywords
- xenon, sevoflurane, cardiac anesthesia, CABG, Bypass surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jan 2011 (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.
The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.
Detailed description
The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions.
Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenon | Experimental | Drug: XenonXenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation. |
| Sevoflurane | Active comparator | Drug: SevofluraneSevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with coronary artery disease scheduled for elective CABG
- Patients willing and able to complete the requirements of this study
- Ejection Fraction > 50%
- EuroSCORE ≤ 8
- men and women >= 50 yrs
Key exclusion criteria (18 listed)
- Lack of informed consent
- EuroSCORE < 8
- MMSE < 24
- Age < 50 years
- COPD GOLD > II, increased need of oxygen
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 |
|---|---|---|
| Xenongaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation | Drug | Xenon |
| Sevofluraneinhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation | Drug | Sevoflurane |
Primary outcome
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation
Time frame: an average of 4 to 6 hours
The feasibility of xenon application compared to sevoflurane application will be assessed by: * The depth of anaesthesia level * The peri-anaesthetic respiratory profile * The peri-anaesthetic haemodynamic profile The following safety parameters will be assessed: * Doses and concentration of study treatments * Trans-esophageal echocardiography * Measures of renal function * Intra-operative blood loss and amount of transfused blood/products * Need for hemodynamic and inotropic support * The patient's regional cerebral tissue oxygenation rSO2 * The incidence of AE and SAE
2 secondary outcomes
Secondary efficacy and safety criteria
Time frame: 6 days
all cause mortality and contentment questioning
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Derived from this study: PubMed 26467531Breuer T, Emontzpohl C, Coburn M, Benstoem C, Rossaint R, Marx G, Schalte G, Bernhagen J, Bruells CS, Goetzenich A, Stoppe C. Xenon triggers pro-inflammatory effects and suppresses the anti-inflammatory response compared to sevoflurane in patients undergoing cardiac surgery. Crit Care. 2015 Oct 15;19:365. doi: 10.1186/s13054-015-1082-7.
- Derived from this study: PubMed 23578862Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.
Related trials for Xenon
RecruitingEarly Phase 1
Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema
Air Trapping, Emphysema
Active, not recruitingPhase 1
Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Regional Phenotyping of CF and Non-CF Bronchiectasis
Cystic Fibrosis, Non-CF Bronchiectasis
Not yet recruitingPhase 2
Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis
Interstitial Lung Disease, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Lung Functional Avoidance Radiotherapy Using Hyperpolarized Xenon MRI
Carcinoma, Non-Small-Cell Lung
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.
Mark Coburn, PD Dr. med. principal investigator
Department of Anesthesiology, 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 3 study testing Xenon and Sevoflurane in people with Xenon and Sevoflurane, 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 6 Oct 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation (time frame: an average of 4 to 6 hours). 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 NCT01285271, which also lists 2 linked publications.
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 6 Oct 2011.