EUCTR2015-003050-41-DK进行中（未招募）1 期
Efficacy of GLP-1 agonists and restrictive vs. liberal FiO2 in patients undergoing coronary artery bypass grafting or aortic valve replacement – a 2-by-2 factorial designed, randomized clinical study - GLP-1 and hyperoxia in CABG/AVR surgery patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained
- •2)= 18 years of age at the time of signing informed consent
- •3)IHD requiring CABG (multi-vessel coronary artery disease or coronary anatomy not suitable for percutaneous coronary intervention) and/or Aortic Valve Disease scheduled for AVR, irrespective of other concomitant valve surgery.
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 900
排除标准
- •1)Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism or history of or active acute pancreatitis.
- •2)Acute (i.e. off hours, within hours surgery), Sub-acute surgery (i.e. the following days are eligible).
- •3)Known allergy towards Exenatide/Byetta or albumin (vehicle).
- •4)On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
- •5)Recipient of any major organ transplant (e.g. lung, liver, heart)
- •6)Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of > 2.5 years in the opinion of the investigator)
- •7)Currently enrolled in, or at least 30 days not yet elapsed since ending participation in other investigational drug trial(s) for the treatment of Diabetes or malignant Obesity investigating the use of GLP-1 agonists or receiving other investigational agent(s). Concomitant participation in other non-pharmacological trials is not an exclusion criterion.
- •8)Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
- •9)Pregnant, based on investigator evaluation (e.g., positive human chorionic gonadotropin test) or currently breast feeding.
- •10)Any condition (e.g., psychiatric illness) or situation that, in the investigator’s opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject’s participation in the study.
研究者
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