USE OF LORAZEPAM FOR PEDIATRIC STATUS EPILEPTICUS (COHORT 2)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。多中心研究的目的是观察劳拉西泮治疗小儿癫痫状态的药代动力学。这项研究有两个队列。队列1是针对可以在主动发作时登记/给药的患者，队列2是针对将选择性登记/给药的患者。队列2的排除标准已更改为，如果患者患有不明原因的肾脏或肝脏疾病，超过正常值的两倍或患者基线值增加2倍，则排除患者。样本量从60例调整到100例，研究延长至2006年5月1日。

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 than 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.