USE OF LORAZEPAM FOR PEDIATRIC STATUS EPILEPTICUS (COHORT 2)

使用劳拉西泮治疗儿童癫痫持续状态（第 2 组）

• 批准号: 7717180
• 负责人: KATHLEEN C BROWN
• 金额: $ 1.37万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717180
• 关键词: Childhood; Computer Retrieval of Information on Scientific Projects Database; Disease; Dose; Drug Kinetics; Enrollment; Exclusion Criteria; Funding; Grant; Hepatic; Institution; Kidney; Lorazepam; Patients; Purpose; Research; Research Personnel; Resources; Sample Size; Source; Status Epilepticus; United States National Institutes of Health; cohort

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of the multi-center study is to look at the pharmacokinetics of lorazepam for the treatment of pediatric status epileticus. The study has two cohorts. Cohort 1 is for patients that can be enrolled/dosed while actively seizing and cohort 2 is for patients that will be electively enrolled/dosed. The exclusion criterion for cohort 2 has been changed to excluded patients if they have unexplained renal or hepatic disease greater that twice the limit than normal or 2-fold increase of the patients baseline value. The sample size has been adjusted from 60 to 100 patients and the study has been extended until May 1, 2006.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 多中心研究的目的是观察劳拉西泮治疗小儿癫痫持续状态的药代动力学。 该研究有两个队列。队列1用于可在主动癫痫发作时入组/给药的患者，队列2用于将选择性入组/给药的患者。队列2的排除标准已变更为：如果患者的不明原因肾脏或肝脏疾病超过正常限值的两倍或患者基线值增加2倍，则将其排除。样本量从60例调整为100例，研究延长至2006年5月1日。