Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,500
- 试验地点
- 1
- 主要终点
- Rate of systemic inflammatory response syndrome
研究概览
简要总结
Congenital heart disease is the most common congenital malformation in the world with high morbidity and mortality. However, there is no data to assess the perioperative outcome of congenital heart disease surgery among Chinese cross-regional population. This study aims to investigate the perioperative outcome of congenital heart disease surgery in childhood from a chinese cross-regional cohort.
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
- 1 Week 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was aged 1 week-18 years
- •Subjects underwent congenital heart disease surgery;
- •Available data to investigate perioperative outcome.
排除标准
- •Cardiac reoperation;
- •Emergency surgery;
- •Interventional procedure within prior 30 days prior to surgery;
- •Missing outcome data.
结局指标
主要结局
Rate of systemic inflammatory response syndrome
时间窗: postoperative day 7 or hospital discharge, whichever occurred first.
Systemic inflammatory response syndrome was determined mainly on (i) Core temperature of \>38.5°C or \<36°C measured by rectal, oral, or central catheter probe; (ii) Tachycardia, defined as a mean heart rate \>2 SD above normal for age in the absence of external stimulus, chronic drugs, or painful stimuli; or otherwise unexplained persistent elevation over a 0.5- to 4-hr time period, or for children \<1 yr old: bradycardia, defined as a mean heart rate \<10th percentile for age in the absence of external vagal stimulus; or otherwise unexplained persistent depression over a 0.5-hr time period; (iii) Mean respiratory rate \>2 SD above normal for age, the prolonged mechanical ventilation defined as ventilation duration \> 48 hrs, or unplanned re-intubation for an acute process not related to underlying neuromuscular disease or the receipt of general anesthesia; (iv) Leukocyte count elevated or depressed for age or \>10% immature neutrophils.
次要结局
未报告次要终点
研究者
Hong Liu
Principal Investigator
Peking Union Medical College
