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临床试验/NCT04093011
NCT04093011Unknown不适用

Perioperative Outcome of Congenital Heart Disease Surgery in Childhood: Results From a Chinese Cross-regional Cohort Study

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 6,500 人开始时间: 2012年1月1日最近更新:
适应症

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

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

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Liu

Principal Investigator

Peking Union Medical College

研究点 (1)

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