Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum levels of Interleukin- 6
研究概览
简要总结
The goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 1 month- 18 years of age
- •Undergoing Cardiac surgery for the first time and requiring CPB
- •Surgeries for both cyatonic and acyanotic heart disease
排除标准
- •Pre-mature babies (< 28 weeks at birth)
- •Prior cardiac requiring CPB
- •Surgeries requiring CPB > 6 hours
- •Surgeries requiring second run of CPB
- •Patients requiring additional steroids during first 24 hours of CICU stay
- •Patient expires within the initial 24 hours CICU stay.
- •Compromised immune system - that is, known immunodeficiency or use of
- •immunomodulatory therapy.
- •Peri-operative presence of two or more clinical or laboratory signs of active infection that were not attributable to any other cause: fever more than 100°F, heart rate or respiratory rate more than the normal range for age, white blood cell count more than 15% of the upper limit of normal, and an elevated C-reactive protein level above baseline.
- •Preoperative mechanical ventilation, and preoperative need of inotropic agents or mechanical circulatory support.
- •Patient already receiving steroids
研究组 & 干预措施
Group M
IV Methylprednisolone
干预措施: Methylprednisolone (Drug)
Group P
IV Normal Saline
干预措施: Saline (Drug)
结局指标
主要结局
Serum levels of Interleukin- 6
时间窗: Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB
serum levels of Interleukin- 6 will be measured using ELISA
Serum levels of CRP
时间窗: Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB
serum levels of CRP will be measured using ELISA
次要结局
- Serum creatinine level(Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB)
研究者
Dr. Muhammad Saad Yousuf
Senior Instructor
Aga Khan University