Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Severe postoperative morbidity
研究概览
简要总结
The intraoperative fluid balance during pediatric cardiac surgery is a very sensitive parameter given the low circulating volume and the complexity of anesthetic management but might be deleterious if inadequately managed. The hypothesis is that a highly positive intraoperative fluid balance increases the incidence of adverse events in the short and long term.
A retrospective observational study including all consecutive children admitted for cardiac surgery with cardiopulmonary bypass (CPB) from 2008 to 2018 in a tertiary children's hospital will be performed. A multivariate analysis will be carried out to study the effect of the fluid balance on the incidence of adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 0-16 years and
- •Cardiac surgery with cardiopulmonary bypass and
- •operated between 2008 and 2018 at the Queen Fabiola University Children's Hospital (tertiary children's hospital)
排除标准
- •ASA (American Society of Anesthesiologists) score of 5
- •Jehovah's Witnesses
- •incomplete hospital record
研究组 & 干预措施
Pediatric cardiac surgery
The group consists of all the children who undergo cardiac surgery in our institution from 2008 to 2018. The age limit was from birth to 16 years old.
干预措施: Fluid balance (Drug)
结局指标
主要结局
Severe postoperative morbidity
时间窗: From intervention until 28 days postoperatively
Severe postoperative morbidity will be characterized as the presence of two or more of the following situations: respiratory failure, prolonged inotropic support, or renal failure. Respiratory failure will be defined as the requirement for mechanical ventilation for \>82 hours at any time from Pediatric Intensive Care Unit admission to the time of tracheal extubation. Prolonged inotropic support will be characterized as hemodynamic support by continuous vasoactive drug infusion for \>48 hours postoperatively (excluding dopamine or dobutamine ≤5 μg/kg/min). Renal failure will be characterized as the worst estimated postoperative creatinine clearance (eCCr) value showing a ≥75% reduction compared with the preoperative baseline eCCr.
次要结局
- Incidence of new infections(From intervention until 28 days postoperatively)
- Incidence of new Neurological deficits(From intervention until 28 days postoperatively)
- Duration of mechanical ventilation(From intervention until 28 days postoperatively)
- PICU and hospital length of stay(From intervention until 28 days postoperatively)
研究者
Denis SCHMARTZ
Head, Department of Anesthesiology
Brugmann University Hospital