Treatment of Hyperglycemia Ischemic Stroke(THIS)Trial

描述(由申请人提供)：这项建议的广泛、长期目标是在随后的大型临床疗效试验中测试严格控制中风前3天的高血糖和静脉注射胰岛素是否会在3个月内产生比不严格的标准治疗更好的患者结果。这项试点临床试验的具体目标是：1)改进一种静脉胰岛素方案，它将比标准的皮下胰岛素治疗方案更好地控制中风前3天的高血糖；2)改进拟议的静脉胰岛素方案，使低血糖(葡萄糖60 mg/dl)。将在不超过20%的受试者中发生；以及3)收集对随后的大型临床疗效试验的优化设计至关重要的信息。要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，以及它们在中风前3天的安全性。该项目与健康相关的是，大约三分之一的急性中风患者患有高血糖，众所周知，胰岛素可以有效地治疗高血糖。然而，一种有效和安全的静脉注射胰岛素方案，特别是对糖尿病合并急性卒中的患者，还没有报道，这种治疗的可能效果也没有得到测试。研究设计是最初的单盲(受试者)急性治疗，然后是最终的双盲结果评估。发病12小时内出现高血糖(大于或等于)180毫克/分升的急性缺血性中风患者将被随机分为皮下胰岛素标准治疗和静脉胰岛素积极治疗两组，比例为1：2。采用的治疗方法为：标准治疗组每日皮下注射胰岛素4次，按滑动胰岛素评分标准；积极治疗组按维持血糖70~130 mg/dl的方案静脉注射胰岛素。在两组中，根据最近的血糖水平，每20-120分钟监测一次血糖，试验性治疗将持续72小时。其他治疗将在两组中指定和标准化。高血糖的长期治疗将根据每个患者的需要进行个体化治疗。其他测量将包括生命体征、血清电解质、血红蛋白A-1C，以及在3个月内对多种临床结果进行全球测试。

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.