The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
研究概览
简要总结
The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.
详细描述
The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital heart defect with two ventricle anatomy and physiology
- •Ages: 0 - 36 months of age
排除标准
- •History of bleeding disorder
- •History of renal disorder
结局指标
主要结局
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
时间窗: Throughout the post operative period
次要结局
- lactate clearance(Throughout the post operative period)
- inotropic requirements(throughout the post operative period)
- establishment of adequate urine output(Throughout the post operative period)
- post-operative occurrence of edema (peripheral and pulmonary)(Througout the post operative period)
- monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay(Throughout the ICU stay)