Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Interstitial colloid osmotic pressure
研究概览
简要总结
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.
The study hypothesis are
- Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
- The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
- Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Congenital heart defect in need of Fontan procedure -
排除标准
- •No parental consent
结局指标
主要结局
Interstitial colloid osmotic pressure
时间窗: Before and after surgery or catheterization
Change in interstitial colloid osmotic pressure
次要结局
未报告次要终点
研究者
Marianne Indrebo
MD Research fellow
Oslo University Hospital
