The effect of inhaled milrinone and inhaled levosimendan in pulmonary hypertension in children with congenital heart disease- A randomized double blinded trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare acute effects of inhaled milrinone and inhaled levosimendan on pulmonary and systemic vascular resistance and on pulmonary blood flows, systemic blood flow and pulmonary to systemic blood flow ratio.
研究概览
简要总结
This study is a Randomised double-blinded parallel group trial to study the acute effects of inhaled milrinone and inhaled levosimendan in pulmonary hypertension in children with congenital heart disease for 12 months in 40 patients. The primary outcome will be acute effects of the drugs on the pulmonary vascular resistance, systemic vascular resistance and pulmonary blood flows, systemic blood flows, pulmonary to systemic blood flow ratio. The secondary outcomes will be acute effects of the drugs on oxygen saturation in aorta, pulmonary artery, mixed venous saturation and2D echocardiography parameters RVOT profile pulmonary artery acceleration time and volume time integral.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with cyanotic or acyanotic heart disease with pulmonary hypertension defined by mean pulmonary artery pressures more than or equal to 25mmHg will be enrolled in the study.
排除标准
- •Patients who did not show response to 100% oxygen during the right heart catheter study.
- •Patients not willing for the study.
结局指标
主要结局
To compare acute effects of inhaled milrinone and inhaled levosimendan on pulmonary and systemic vascular resistance and on pulmonary blood flows, systemic blood flow and pulmonary to systemic blood flow ratio.
时间窗: After completion of nebulization of each drug that is after 15minutes
次要结局
- To compare the acute effects of inhaled milrinone and inhaled levosimendan on oxygenation saturain aorta , pulmonary artery and mixed venous saturation and 2D echocardiography parameters RVOT doppler profile pulmonary artery acceleration time and volume time integral(After the completion of inhalation of the drugs over 15 to 20 minutes)
研究者
Dr Rajeswari N
Apollo hospitals enterprises limited