Copeptin- Relevance as a Perioperative Marker in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change of Copeptin concentrations
研究概览
简要总结
This study evaluates the relevance of Copeptin in children with congenital heart disease undergoing cardiac surgery with the need of cardiopulmonary bypass. Three blood samples are taken of each patient. The first and second sample are collected in the operation room before and after the procedure and the third sample on the first postoperative day at the intensive care unit.
详细描述
Objective:
Vasopressin is a hormone secreted by the posterior pituitary gland. Its main functions are constriction of blood vessels and reabsorption of water and thereby regulating water balance and hemodynamics of the body. Copeptin is a cleavage product in the synthesis of vasopressin and is released in equimolar amounts. Its stability makes it easier to determine the amount of vasopressin. It is known, that the use of a heart-lung machine in cardiac procedures has effects on the water balance of the body and may affect the vasopressin secretion.
The aim of this prospective clinical trial is, to figure out if copeptin would be suitable for perioperative risk evaluation in neonates and children with congenital heart disease after surgery with the use of a heart-lung machine.
Hypotheses:
The primary outcome endpoint of this study is the change in copeptin concentration perioperatively in patients with congenital heart disease, with the use of heart-lung machine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤6 years of age
- •need of HLM for surgery
- •Informed consent of parents
- •not participating in other studies
排除标准
- •Preoperative ventilatory support
- •Preoperative circulatory support (ECMO, VAD)
- •Diabetes insipidus
- •Preoperative CPR
- •Preoperative shock
- •Preoperative sepsis
- •Preoperative vasopressin application
结局指标
主要结局
Change of Copeptin concentrations
时间窗: baseline and up to one day
Change of Copeptin concentrations between the baseline and first postoperative measurement
次要结局
- Intubation(up to one day)
- Cardiopulmonary bypass(up to one day)
- Complexity of procedures(up to one day)
- ICU stay(up to one day)
研究者
Claudia Herbst
Dr. med. univ.
Medical University of Vienna