NCT02058940已完成4 期
Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria
研究概览
简要总结
The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults ≥18 years
- •Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay >48 hours
- •Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL
- •Informed consent obtained via proxy
排除标准
- •Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females
- •Type 1 diabetes mellitus
- •History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)
- •Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min
- •Known history of gastroparesis
- •History of surgery on stomach, esophagus or duodenum
- •Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome
- •Concurrent steroid use or planned post-operative steroid use
- •History of organ transplantation
- •Brain death or suspected imminent brain death within the next 72 hours
- •Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg for greater than 15 minutes and refractory to medical intervention
- •Currently enrolled in another investigational drug or device protocol
- •Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration
- •Known allergy to exenatide
研究组 & 干预措施
Exenatide
Experimental
干预措施: Exenatide (Drug)
结局指标
主要结局
Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria
时间窗: Over 48 hours from infusion initiation
Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (\<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy. The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (\<40 mg/dL) or nausea requiring exenatide discontinuation.
次要结局
- Median Insulin Use(Over 48 hours from infusion initiation)
- Percentage of Patients Requiring Rescue Insulin Infusion Protocol(Over 48 hours from infusion initiation)
- Percentage of Hypoglycemic Episodes (<80 mg/dL)(Over 48 hours from infusion initiation)
- Median Daily Cerebral Perfusion Pressure(Over 48 hours from infusion initiation)
- Percentage of Hypotensive Episodes (SBP<100 mmHg)(Over 48 hours from infusion initiation)
- Exenatide Elimination Rate Constant After Discontinuation of Infusion(24 hours)
- Median Intensive Care Unit Length of Stay(From enrollment to 30 days post study drug discontinuation)
- Median Hospital Length of Stay(From enrollment to 30 days post study drug discontinuation)
- Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)(Over 48 hours from infusion initiation)
- Median Glucose Concentration During Exenatide Infusion(Over 48 hours from infusion initiation)
- Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)(Over 48 hours from infusion initiation)
- Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion(24 hours)
- Percentage of Glucose Measurements Within Goal Range(Over 48 hours from infusion initiation)
- Glycemic Variability(Over 48 hours from infusion initiation)
- Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)(Over 48 hours from infusion initiation)
- Median Daily Intracranial Pressure(Over 48 hours from infusion initiation)
- Percentage of Patients Experiencing Metabolic Crisis(Over 48 hours from infusion initiation)
- Correlation of Exenatide Concentrations With Creatinine Clearance(Over 48 hours from infusion initiation)
研究者
研究点 (1)
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