The safety and feasibility of delivering xenon to patients before and after coronary artery bypass graft implantation: a pilot studyAbbreviated study title:A pre- and post-Coronary Artery bypass graft implantation Disposed Application of Xenon – CArDiAX - CArDiAX

Clinical Trials Center Aachen, University of Aachen0 个研究点开始时间: 2010年12月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•if women, then without childbearing potential, i.e. hysterectomy, sterilization, post-menopausal (late of last menses > 2 yrs ago)
•ASA Score II-IV
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Lack of informed consent
•EuroSCORE > 8
•MMSE < 24
•Age < 50 years
•COPD GOLD > II and increased need of oxygen
•Renal dysfunction defined as creatinine > 1.5 mg/dl or GFR < 60 ml/min (stadium NKF = III)
•Liver function disorders (Liver enzymes > twice the upper limit)
•Acute coronary syndrome during the last 24 hours; hemodynamic instability
•requirement of inotropic support
•Off-pump-surgery
•Disabling neuropsychiatric disorders (severe dementia, Alzheimer’s disease, schizophrenia, depression)
•History of stroke with residuals
•increased intracranial pressure
•Hypersensitivity to the study anaesthetics
•pregnancy and lactation period
•women of childbearing potential
•Presumed uncooperativeness or legal incapacity
•participation in a concomitant trial

发起方

Clinical Trials Center Aachen, University of Aachen