NCT00882492已完成1 期
Identifying a Novel Mechanism for Perioperative Hyperglycemia Identifying a Novel Mechanism for Perioperative Hyperglycemia in Cardiac Surgery: A Role for Incretins
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels.
研究概览
简要总结
This is a medical research study designed to see if an infusion of a naturally occurring hormone, GLP-1, works when used to decrease blood sugar during cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female age (18-80 years),
- •ability to provide informed consent,
- •elective CABG with or without single or multivalve repair or replacement, and/ or
- •single or multivalve repair or replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery).
排除标准
- •concomitant surgery (e.g. carotid endarterectomy),
- •emergent surgery,
- •current steroid use,
- •insulin dependent diabetes mellitus (IDDM),
- •cardiac surgery without the use of cardiopulmonary bypass (e.g. off-pump CABG),
- •current use of positive intravenous inotropic agents,
- •serious intercurrent illness (endocarditis, sepsis, active malignancy requiring treatment) or active infection,
- •known substance abuse,
- •receipt of an investigational drug or device within 30 days prior to surgery,
- •known allergy to any of the following: GLP-1, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine,
- •Sulfonylurea medication administration on morning of surgery (such as, tolbutamide, tolazamide (Tolinase), chlorpropamide (Diabinese). glipizide (Glucotrol, Glucotrol XL), glyburide (Micronase, Glynase PresTabs, and DiaBeta), glimepiride (Amaryl),
- •Major end organ dysfunction defined as:
- •Cardiac: Left ventricular ejection fraction (LVEF) < 30% by left ventriculography or echocardiogram (within 90 days prior to randomization), current use of positive intravenous inotropic agents, preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO);
- •Renal: preoperative serum Creatinine > 2.0 mg/dL;
- •Hepatic: aspartate aminotransferase (AST) or alanine transferase (ALT) > 2.5 x upper limit normal;
- •Hematologic: preoperative hematocrit (HCT) < 30%, platelet count < 100,000/mm3, history of (or family history of) bleeding or clotting disorder;
- •Patients with a history of or risk factors for acute pancreatitis (i.e. ethanol abuse, gall stones) will be excluded from this study,
- •Pregnant or breastfeeding females, or
- •any other condition that, in the opinion of the investigator, may compromise the safety of the subject or would preclude the subject from successful completion of the study.
研究组 & 干预措施
2
Placebo Comparator
This is a continuous infusion of normal saline solution infusion as placebo at (1.5 pmol/kg/min)
干预措施: normal saline solution placebo (Biological)
结局指标
主要结局
The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels.
时间窗: During surgery and 24 hours after
次要结局
未报告次要终点
研究者
研究点 (2)
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