Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Lactate clearance
研究概览
简要总结
The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.
详细描述
Pediatric patients undergoing cardiac surgery are at risk for adverse clinical outcomes due a inadequate tissue perfusion. Recent studies have been demonstraded which the monitorization of continuos central venous saturation could be benneficial. There is evidence that monitoring continues venous oxygen saturation (ScvO2) can be beneficial in patient outcomes, guided by ScvO2 therapy has been associated with improved outcomes in resuscitation of critically ill patients with sepsis and after congenital heart surgery complexa. The early detection and treatment of tissue hypoxia can prevent morbidity and mortality. tissue hypoxia may be a result of the imbalance between supply (DO2) and oxygen consumption (VO2). If the fault supply, oxygen consumption is maintained by increased oxygen extraction resulting in decreased central venous oxygen saturation
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery with cardiopulmonary bypass
- •Written informed consent
排除标准
- •Cardiac arrhythmia
- •Emergency operation
- •Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
- •Neoplasia
- •Heart transplant
- •Participation in another study
结局指标
主要结局
Lactate clearance
时间窗: at the beginning of surgery up to 24 hours after surgery
(\[lactate initial - lactate delayed\]/lactate initial) ×100%
次要结局
- Cardiac complications(within 30 days after cardiac surgery)
- Renal complications(within 30 days after cardiac surgery)
- Infection(within 30 days after cardiac surgery)
- Length of ICU stay(within 30 days after cardiac surgery)
- Length of Mechanical ventilation(within 30 days after cardiac surgery)
- Vasopressors and inotropic therapy(within 30 days after cardiac surgery)
- Length of hospital stay(within 30 days after cardiac surgery)
研究者
Filomena R B G Galas
Associate Professor of Anesthesiology Departament
Instituto do Coracao