Treatment of Hyperglycemia Ischemic Stroke(THIS)Trial

描述（由申请人提供）：本提案的广泛、长期目标是在随后的大型临床疗效试验中测试，在卒中的前3天使用静脉注射胰岛素严格控制高血糖是否会在3个月时比不太严格的标准治疗获得更好的患者结局。 该初步临床试验的具体目的是：1）改进静脉内胰岛素方案，该方案将在卒中的前3天内比标准皮下胰岛素治疗方案更好地控制高血糖症; 2）改进拟定的静脉内胰岛素方案，使得低血糖症（葡萄糖<60 mg/dl.）将在不超过20%的受试者中发生; 3）收集后续大型临床疗效试验优化设计所必需的信息。 收集的基本信息包括比较两种胰岛素治疗方案对血糖水平的影响，以及卒中前3天的安全性。 该项目的健康相关性在于，所有急性中风患者中约有三分之一患有高血糖症，而众所周知，胰岛素可有效治疗高血糖症。 然而，一个有效的和安全的静脉注射胰岛素的协议，特别是对糖尿病患者急性中风，尚未报告，这种治疗的可能疗效尚未得到测试。 研究设计为初始单盲（受试者）急性治疗，随后进行最终双盲结局评估。 在发病后12小时内发生急性缺血性卒中且高血糖（≥）180 mg/dl的患者将分别以1：2的比例随机接受皮下胰岛素标准治疗或静脉胰岛素积极治疗。 使用的方法是根据滑动胰岛素量表每天4次皮下注射胰岛素治疗标准治疗组的患者，根据设计用于维持血糖水平70-130 mg/dl的方案静脉注射胰岛素治疗积极治疗组的患者。 在两组中，根据最近的血糖水平，每20-120分钟监测一次血糖，实验治疗将持续72小时。 其他治疗将在两组中指定和标准化。 高血糖症的长期治疗将根据每位患者的需求进行个性化。 其他测量将包括生命体征、血清电解质、血红蛋白A-1C和3个月时多项临床结局的总体测试。

DESCRIPTION (provided by applicant): The broad, long-term objectives of this proposal are to test, in a subsequent large clinical efficacy trial, if strict control of hyperglycemia in the first 3 days of stroke, with intravenous insulin, will result in better patient outcomes at 3 months than less strict, standard treatment. The specific aims of this Pilot Clinical Trial are: 1) to refine an intravenous insulin protocol that will control hyperglycemia in the first 3 days of stroke better then a standard subcutaneous insulin treatment protocol; 2) to refine the proposed intravenous insulin protocol so that hypoglycemia (glucose<60 mg/dl.) will occur in no more than 20% of subjects; and 3) to collect information essential for an optimized design of a subsequent, large clinical efficacy trial. The essential information to be collected includes comparison of the two insulin treatment protocols for their effect on blood glucose levels, and their safety in the first 3 days of stroke. The health-relatedness of this project is that approximately one third of all acute stroke patients are hyperglycemic, and insulin is well known to effectively treat hyperglycemia. However, an effective and safe intravenous insulin protocol, especially for diabetic patients with acute stroke, has not been reported, and the possible efficacy of such treatment has not been tested. The research design is an initial single-blinded (subjects) acute treatment followed by a final double-blind outcome assessment. Patients with acute ischemic stroke within 12 hours from onset and hyperglycemia (greater than or equal to) 180 mg/dl will be randomized to either standard treatment with subcutaneous insulin or aggressive treatment with intravenous insulin in a 1:2 ratio, respectively. The methods to be used are to treat patients in the standard treatment group with subcutaneous insulin 4 times daily, according to a sliding insulin scale, and patients in the aggressive treatment group with intravenous insulin according to a protocol designed to maintain the blood glucose level 70-130 mg/dl. In both groups, blood glucose will be monitored every 20-120 minutes, depending on the most recent glucose level, and the experimental treatment will continue for 72 hours. Other treatments will be specified and standardized in both groups. Long-term treatment of hyperglycemia will be individualized according to each patient's needs. Additional measurements will include vital signs, serum electrolytes, hemoglobin A-1C, and a global test for multiple clinical outcomes at 3 months.