Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Neonates and Preterm Infants
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Steady state concentration of dopamine (Css) at 2mcg/kg/min
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of dopamine which is used as treatment of hypotension in neonate and preterm infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted at NICU in Seoul National University Hospital, Seoul Asan Hospital or Severance Hospital
- •Infants who were diagnosed with hypotension
排除标准
- •Congenital heart disease
- •Chromosomal anomaly
- •Treated with ECMO or CRRT
- •Arrhythmia
- •Hypovolemic state
研究组 & 干预措施
Dopamine treatment
干预措施: Dopamine (Drug)
结局指标
主要结局
Steady state concentration of dopamine (Css) at 2mcg/kg/min
时间窗: After continuous infusion for more than 30 minutes at 2mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 20mcg/kg/min
时间窗: After continuous infusion for more than 30 minutes at 20mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 5mcg/kg/min
时间窗: After continuous infusion for more than 30 minutes at 5mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 10mcg/kg/min
时间窗: After continuous infusion for more than 30 minutes at 10mcg/kg/min
dopamine drug level in blood
Steady state concentration of dopamine (Css) at 15mcg/kg/min
时间窗: After continuous infusion for more than 30 minutes at 15mcg/kg/min
dopamine drug level in blood
次要结局
- Blood pressure in mmHg at 2mcg/kg/min(After continuous infusion for more than 30 minutes at 2mcg/kg/min)
- Blood pressure in mmHg at 5mcg/kg/min(After continuous infusion for more than 30 minutes at 5mcg/kg/min)
- Fractional shortening from Echocardiography(After continuous infusion for more than 30 minutes at 20mcg/kg/min)
- Tei index from Echocardiography(After continuous infusion for more than 30 minutes at 20mcg/kg/min)
- Blood pressure in mmHg at 10mcg/kg/min(After continuous infusion for more than 30 minutes at 20mcg/kg/min)
- Heart rate(After continuous infusion for more than 30 minutes at 20mcg/kg/min)
- Ejection fraction from Echocardiography(After continuous infusion for more than 30 minutes at 20mcg/kg/min)
- VTI (velocity time integral) from Echocardiography(After continuous infusion for more than 30 minutes at 20mcg/kg/min)