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临床试验/NCT02306057
NCT02306057已完成不适用

Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014年11月最近更新:
适应症

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

  1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
  2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
  3. 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

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

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne Indrebo

MD Research fellow

Oslo University Hospital

研究点 (1)

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