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临床试验/NCT04548167
NCT04548167已完成不适用

Prolonged Cardiopulmonary Bypass Time as Predictive Factor for in Hospital Infection

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 7,064 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,064
试验地点
1
主要终点
Extracorporeal circulation time during surgery (minutes)

研究概览

简要总结

This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.

详细描述

Infectious complications after cardiovascular surgery, especially in operations that use cardiopulmonary bypass (CPB), is associated with significant morbidity and increase in peri-operative mortality. Prolonged CPB usage could be predictive for early bloodstream infection following cardia surgery. This study is to analyse the demographics and microbiological factors concerning patients undergoing cardio surgical intervention using CPB complicated with bloodstream infection (BSI) postoperatively.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients undergoing cardiac surgery

排除标准

  • patients having active or previous endocarditis
  • patients whose causative microorganism of postoperative BSI was identical to that isolated from preoperative or intraoperative samples
  • patients with common skin colonized microorganisms, such as coagulase-negative Staphylococci, Viridans group Streptococci, Corynebacterium species, Bacillus species, Propionibacterium species, and Aerococcus species or Micrococcus species, which were isolated from only a single blood sample and without evidence of clinical sepsis, because contamination was considered.

结局指标

主要结局

Extracorporeal circulation time during surgery (minutes)

时间窗: one time assessment at baseline

Extracorporeal circulation time during surgery (minutes)

In-hospital mortality (number) for patients with BSI vs those without BSI after a cardiovascular surgery

时间窗: during hospital stay (usually up to 4 weeks)

In-hospital mortality is defined as death before discharge

Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay (number)

时间窗: during hospital stay (usually up to 4 weeks)

Surgical intervention rate (Incidence of cardiovascular re-operation) during the initial hospital stay

Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)

时间窗: within 7 days after a cardiovascular surgery

Incidence of bloodstream infection (BSI) in postoperative period (clinical evidence of sepsis with laboratory-confirmed bacteraemia from blood sample)

次要结局

  • Incidence of cardiovascular events (stroke, myocardial infarction) during hospitalization(during hospital stay (usually up to 4 weeks))
  • Incidence of cardiovascular re-operation during the follow up(after hospital discharge until follow- up assessment (up to 10 years))
  • Incidence of cardiovascular events (stroke, myocardial infarction) during follow-up(after hospital discharge until follow- up assessment (up to 10 years))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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