Clinical Laboratory Tests 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 and results of hematology, chemistry, liver function, lactate, blood gases, and pregnancy tests
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

血液学、生化检测、肝功能、乳酸、血气分析及妊娠试验的时序与检测结果
研究概况
本研究为一项II期随机双盲安慰剂撤药对照研究，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。研究目标包括：明确持续至少12小时的稳定输注方案中，硝普钠对血压的作用持续时长；以及评估在持续给药至少12小时后暂时中断输注、并经历30分钟双盲观察阶段时，出现反跳性高血压的潜在可能性。受试人群为年龄未满17岁、需接受药物血压调控至少12小时的儿童。