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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
  Purpose

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.


Condition Intervention Phase
Xenon
Sevoflurane
Anesthetics, Inhalation
Coronary Disease
Coronary Artery Bypass
Drug: Xenon
Drug: Sevoflurane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenon
Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
Drug: Xenon
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
Active Comparator: Sevoflurane
Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the 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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285271

Locations
Germany
Department of Anesthesiology, University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
German Research Foundation
Investigators
Principal Investigator: Mark Coburn, PD Dr. med. Department of Anesthesiology, University Hospital Aachen
  More Information

No publications provided by RWTH Aachen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01285271     History of Changes
Other Study ID Numbers: 10-017, 2010-023942-63
Study First Received: January 24, 2011
Last Updated: October 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
xenon
sevoflurane
cardiac anesthesia
CABG
Bypass surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Sevoflurane
Xenon
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014