A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon
CArDiAX
The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 27, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 6, 2011
October 1, 2011
4 months
January 24, 2011
October 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
an average of 4 to 6 hours
Secondary Outcomes (2)
Secondary efficacy and safety criteria
6 days
all cause mortality and contentment questioning
1 year
Study Arms (2)
Xenon
EXPERIMENTALXenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
Sevoflurane
ACTIVE COMPARATORSevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
Interventions
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Lack of informed consent
- EuroSCORE \< 8
- MMSE \< 24
- Age \< 50 years
- COPD GOLD \> II, increased need of oxygen
- Renal dysfunction
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RWTH Aachen Universitylead
- German Research Foundationcollaborator
Study Sites (1)
Department of Anesthesiology, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Related Publications (2)
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.
PMID: 26467531DERIVEDStoppe 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.
PMID: 23578862DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Coburn, PD Dr. med.
Department of Anesthesiology, University Hospital Aachen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 27, 2011
Study Start
May 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 6, 2011
Record last verified: 2011-10