National Acute Brain Injury Study: Hypothermia II

国家急性脑损伤研究：体温过低 II

• 批准号: 6790640
• 负责人: Guy L. Clifton
• 金额: $ 331.53万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-15 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6790640
• 关键词: body temperature regulation; brain injury; clinical research; clinical trial phase III; emergency care; health care service evaluation; human subject; human therapy evaluation; hypothermia; intracranial pressure; medical complication; outcomes research; patient oriented research; psychological tests

DESCRIPTION (provided by applicant): This proposed project, the National Acute Brain Injury Study: Hypothermia II (NABIS:H In will be a multi-center, prospective, randomized Phase III clinical trial in which standard management at hypothermia (33 degrees C) for 48 hours is tested against standard management at normothermia in patients with severe brain injury (GCS<8), age 16-45 years, and with admission temperature less than or equal to 35 degrees C . The primary outcome measure will be the dichotomized Glasgow Outcome Scale at 6 months after injury (Good Recovery/Moderate Disability vs. Severe Disability/Vegetative/Dead). The sample size of 220 patients will detect an absolute difference of 17% in the percentage of poor outcomes in the two groups at a power of 80%. The selection of this population was based on findings from the original National Acute Brain Injury Study: Hypothermia (NABIS:H I). In that study, with a sample size of 392, hypothermia was induced beginning <6 hours after injury, reaching 33 degrees C by 8.4 + or - 3 hours after injury, and maintaining hypothermia for 48 hours. The null hypothesis was confirmed, with no difference in the percentage of patients making a poor recovery (Severe Disability, Vegetative, Dead) at 6 months after injury (Hypothermia 57%, Normothermia 57%, NS). In 52 patients age >45 years, there were more poor outcomes in the hypothermia group (Hypothermia 89%, Normothermia 69%, p=0.08) due to increased medical complications. However, in 81 patients (22% of 366 patients with complete data) who were age 16-45 years with admission temperature less than or equal to 35 C, maintenance of hypothermia was associated with a marked decrease in the percentage of poor outcomes (Hypothermia, 52%, Normothermia 76%, p=0.02) with no difference in complication rates. The effect was found in all of the 4 high-enrollment centers, and there were no confounding variables that could have explained the difference in outcomes. The entire treatment effect in this subgroup was to shift patients from Severe Disability (poor outcome) to Moderate Disability (good outcome). We believe that the finding is related to a very short treatment window for hypothermia induction. The proposed study prospectively tests whether maintenance of hypothermia present on admission results in better outcome than current management.

描述（由申请人提供）：本拟议项目，国家急性 脑损伤研究：低温 II (NABIS:H In 将是一个多中心、 前瞻性、随机 III 期临床试验，其中标准管理 与标准管理相比，在低温（33 摄氏度）下持续 48 小时进行了测试 重度脑损伤（GCS<8）、年龄 16-45 岁、以及 入场温度≤35℃。主要结局指标将是受伤后 6 个月时的二分格拉斯哥结局量表（良好） 恢复/中度残疾与严重残疾/植物人/死亡）。样品 220 名患者的规模将检测到 17% 的绝对差异 两组不良结果的百分比为 80%。评选 该人群的调查结果基于原始国家急性大脑研究的发现 损伤研究：体温过低 (NABIS:H I)。在该研究中，样本量为 392、受伤后 6 小时内开始诱导体温过低，达 33 摄氏度 伤后8.4±3小时，并维持低温48小时。这 零假设得到证实，患者比例没有差异 术后 6 个月恢复情况不佳（严重残疾、植物人、死亡） 损伤（体温过低 57%，体温正常 57%，NS）。在 52 名年龄 >45 岁的患者中， 低温组的不良结果更多（低温组 89%， 由于医疗并发症增加，体温正常69%，p=0.08）。然而，在 81 名年龄在 16-45 岁之间的患者（366 名拥有完整数据的患者中的 22%） 进场温度小于或等于35℃，维护 体温过低与贫困人口比例显着下降有关 结果（体温过低，52%，体温正常76%，p=0.02）， 并发症发生率。在所有 4 个高入学率中都发现了这种效果 中心，并且没有混杂变量可以解释 结果的差异。该亚组的整体治疗效果是 将患者从严重残疾（预后不良）转变为中度残疾 （好的结果）。我们相信这一发现与一个非常短的 低温诱导的治疗窗口。拟议的研究前瞻性 测试入院时维持低温是否效果更好 成果优于当前管理层。