The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
研究概览
简要总结
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
详细描述
All patients whom on admission to the ICU (surgical, burn, & cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age > 21 to 75 years of age.
- •All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
- •Able to obtain patient or proxy consent.
排除标准
- •Current diagnosis of malignancy.
- •Type 1 diabetes.
- •Inability to obtain informed consent.
- •On any Phase 1 trial.
研究组 & 干预措施
GLP-1
干预措施: Glucagon-Like Peptide-1 (Drug)
Saline
干预措施: Saline (Drug)
结局指标
主要结局
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
时间窗: 2 years
次要结局
- Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment(2 years)