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

Coronary Disease Clinical Trial

— CArDiAX  

Official title:

The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285271
• Other study ID #: 10-017
• Secondary ID: 2010-023942-63
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2011
• Last updated: October 5, 2011
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthetics, Inhalation
• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Sevoflurane
• Xenon

Intervention

Drug:
• Xenon
gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
• 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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Hospital Aachen	Aachen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	6 days	Yes
Secondary	all cause mortality and contentment questioning	Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.	1 year	No