Treatment of Hyperglycemia Ischemic Stroke(THIS)Trial

描述（由申请人提供）：本提案的广泛和长期目标是在随后的大型临床疗效试验中测试，是否在中风的前3天严格控制高血糖，静脉注射胰岛素，在3个月时比不严格的标准治疗产生更好的患者结果。该试点临床试验的具体目的是：1)改进静脉注射胰岛素方案，以更好地控制中风前3天的高血糖，而不是标准的皮下胰岛素治疗方案；2)完善静脉注射胰岛素方案，使低血糖（血糖<60 mg/dl）发生率不超过20%；3)为后续大型临床疗效试验的优化设计收集必要的信息。需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。这个项目与健康的关系是，大约三分之一的急性中风患者是高血糖患者，而胰岛素是众所周知的有效治疗高血糖的药物。然而，一种有效和安全的静脉注射胰岛素方案，特别是对急性中风的糖尿病患者，还没有报道，而且这种治疗的可能效果还没有经过测试。研究设计是最初的单盲（受试者）急性治疗，然后是最后的双盲结果评估。发病后12小时内出现高血糖（大于或等于180mg /dl）的急性缺血性卒中患者将按1:2的比例随机分为皮下胰岛素标准治疗组和静脉胰岛素积极治疗组。采用的方法是，标准治疗组患者每日皮下注射胰岛素4次，根据滑动胰岛素量表，积极治疗组患者每日静脉注射胰岛素，根据旨在维持血糖水平70-130 mg/dl的方案。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。其他治疗方法将在两组中指定和标准化。高血糖的长期治疗将根据每位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3个月时多种临床结果的全球测试。

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.