Infusion 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

Timing, duration, and flow rate of study drug infusion and materials used
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

研究药物输注的时机、持续时长与流速及所用耗材

研究描述
本研究为一项II期随机双盲安慰剂撤药试验，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。本研究的核心目标包括：明确至少持续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30分钟盲法阶段时，出现反跳性高血压的潜在可能性。纳入标准为年龄未满17岁、需接受至少12小时药物性血压控制的儿童。