Comparison Of Efficacy Of Levosimendan Versus Milrinone In Catecholamine Resistant Septic Shock With Myocardial Dysfunction In Children : A Single-Center, Open-Label Randomized controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- improvement of cardiac function based on fractional shortening and cardiac index (by 2D ECHO), Heart rate & Blood pressure (age & sex adjusted), lactate levels.
研究概览
简要总结
- Patients presenting to Paediatric department of AIIMS Patna (meeting inclusion criteria) will be randomly allocated in 1:1 ratio to two independent treatment groups using opaque sealed envelope method:
Group A: Receives levosimendan as an ionodilator drug therapy
Group B: Receives milrinone as an ionodilator drug therapy
After sample selection as per inclusion criteria after randomization children were started on either milrinone or levosimendan. As levosimendan is in powder form, it will be diluted in 5ml normal saline (standard dilution) to make clear fluid. Milrinone is available as clear fluid and both of these drug is stable for more than 24 hours at room temperature when given as an infusion However if shock persists after the study protocol treating team may further decide the use of any inotrope as open label as per type of shock & clinical profile of the patient using their description
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •All the patients admitting in Paediatric emergency and pediatric intensive care unit, AIIMS Patna, with diagnosis of catecholamine resistant septic shock with and cardiac Index less than 3.3L/MIN/M2.
排除标准
- •Patient requiring CPR at presentation Cardiomyopathy, cardiothoracic surgery within the previous 14 days.
- •congenital heart disease.
结局指标
主要结局
improvement of cardiac function based on fractional shortening and cardiac index (by 2D ECHO), Heart rate & Blood pressure (age & sex adjusted), lactate levels.
时间窗: 1 DAY
次要结局
- Time taken for improvement in cardiac function, survival outcome.
研究者
Dr. Pawan Kumar
AIIMS, Patna