Impact of Pulsatile CPB on Vital Organ Recovery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Changes in plasma proteins
研究概览
简要总结
This research study is about the effect heart-lung bypass procedures have on the vital organs (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood continuously through the body and the other pumps the blood with repeated pulses. Both pumps are approved for clinical use by the FDA. Although 90% of institutions still use non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during surgery.
The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys) respond differently to one method than they do to the other. Approximately 300 children will take part in this research at the Hershey Medical Center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients recruited from Penn State Children's Hospital undergoing cardiac surgery with cardiopulmonary bypass.
排除标准
- •Patients older than 17 years will be excluded.
研究组 & 干预措施
1
Non-pulsatile Group (conventional)
2
Pulsatile group (Alternate)
结局指标
主要结局
Changes in plasma proteins
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Akif Undar
Professor of Pediatrics, Surgery, & Bioengineering
Milton S. Hershey Medical Center