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临床试验/NCT03141450
NCT03141450已完成不适用

Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Mahidol University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
plasma concentration of cefazolin in pediatric cardiopulmonary bypass

研究概览

简要总结

Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age < 7 years old
  • undergoing elective cardiac surgery with cardiopulmonary bypass
  • receive cefazolin as prophylactic antibiotic

排除标准

  • Known or family history of penicillin or cephalosporins allergy
  • Coexisting liver or renal disease
  • Previous infection or received any antibiotics within 4 weeks
  • Previous surgery with median sternotomy
  • Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes
  • Severe hemodynamic instability during the operation, requiring mechanical circulatory support

结局指标

主要结局

plasma concentration of cefazolin in pediatric cardiopulmonary bypass

时间窗: 12 hours

plasma concentration of cefazolin

次要结局

  • incidence of surgical site infection after elective pediatric cardiac surgery(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saowaphak Lapmahapaisan

Asst. Prof.

Mahidol University

研究点 (1)

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