Protocol Deviation Dataset in A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects

Protocol deviation information, follow-up, and whether reportable to the institutional review board
Study Description
A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued. Children less than 17 years of age who require pharmacologic blood pressure control for at least 12 hours

方案偏离信息、随访情况，以及是否需向伦理审查委员会（Institutional Review Board）报告。
研究描述
本研究为一项II期随机双盲安慰剂对照撤药研究，旨在评估硝普钠（sodium nitroprusside, SNP）在儿科受试者中的疗效、安全性与耐受性。研究核心目标包括：明确持续至少12小时的稳定输注方案下，硝普钠对血压的作用持久性；以及评估在持续输注硝普钠至少12小时后临时中断输注、进入为期30分钟的盲法阶段时，出现反跳性高血压的可能性。纳入标准为年龄小于17岁、需接受至少12小时药物血压控制的儿童受试者。