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A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon (CArDiAX)

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01285271
First received: January 24, 2011
Last updated: October 5, 2011
Last verified: October 2011

January 24, 2011
October 5, 2011
May 2011
September 2011   (final data collection date for 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 ] [ Designated as safety issue: Yes ]

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
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation [ Time Frame: an average time frame of 4 - 6 hours ] [ Designated as safety issue: Yes ]

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
Complete list of historical versions of study NCT01285271 on ClinicalTrials.gov Archive Site
  • Secondary efficacy and safety criteria [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

    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
  • all cause mortality and contentment questioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.
Same as current
Not Provided
Not Provided
 
A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Xenon
  • Sevoflurane
  • Anesthetics, Inhalation
  • Coronary Disease
  • Coronary Artery Bypass
  • Drug: Xenon
    gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
  • Drug: Sevoflurane
    inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation
  • Experimental: Xenon
    Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
    Intervention: Drug: Xenon
  • Active Comparator: Sevoflurane
    Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
    Intervention: Drug: Sevoflurane
Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schälte 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Women of childbearing potential
  • Presumed uncooperativeness or legal incapacity
  • Participation in a concomitant trial
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01285271
10-017, 2010-023942-63
No
RWTH Aachen University
RWTH Aachen University
German Research Foundation
Principal Investigator: Mark Coburn, PD Dr. med. Department of Anesthesiology, University Hospital Aachen
RWTH Aachen University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP