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临床试验/NCT04281706
NCT04281706已完成不适用

Impact of Etomidate vs. Propofol on Development of Sepsis and Infectious Complications Post Cardiac Surgery

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 1,495 人开始时间: 2019年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,495
试验地点
1
主要终点
Sepsis

研究概览

简要总结

The aim of this retrospective before-after-study is to evaluate the potential association of etomidate vs. propofol as an induction agent for major cardiac surgery on infectious post-operative complications.

The investigators hypothesize that etomidate increases the rate post-operative infectious complications in cardiosurgical patients.

详细描述

Etomidate had been a standard induction agent as it results in increased hemodynamic stability compared to propofol. This is seen as a major advantage in patients that frequently have a fragile haemodynamic situation.

A major side effect of Etomidate is the resulting adrenal dysfunction, which hampers the bodies stress response and has been shown to cause a higher mortality in infectious contexts such as sepsis. It remains unclear to what extend this attenuated stress response has an impact on the post-operative context in cardiosurgical patients. First preliminary data show that patients receiving Etomidate as an induction agent are more prone to infection than those receiving a different agent, a definitive correlation is nevertheless still lacking.

This is a retrospective before-after-study comparing the rate of infectious complications in patients receiving either valve and/or coronary cardiac surgery at the Charité - Universitätsmedizin Berlin between October 1st, 2012 and January 31th, 2015. On October 1st, 2013 the standard operating procedures for anesthesia for cardiac surgery were amended and the induction agent at the Charité - Universitätsmedizin Berlin was switched from Etomidate to Propofol. The investigators are therefore comparing patients undergoing cardiac surgery between October 1st, 2012 and September 30th, 2013 as the Etomidate group with patients undergoing surgery between February 1st, 2014 and January 31st, 2015 as the Propofol group. The gap in between the two groups (October 1st, 2013 - January 31st, 2014) was defined as a washout phase to account for a potential delay in implementation of the renewed standard operating procedures. Patients will be investigated unmatched as well as matched according to (Age, Body Mass Index, American Society of Anesthesiologists physical status classification system (ASA), New York Heart Association Functional Classification (NYHA), Surgical Mode and Diabetes). The data for both groups will be acquired from the 2 electronic patient data management systems at our hospital (COPRA System, Sasbachwalden, Germany, and SAP, Walldorf, Germany).

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years of age
  • Valve and/or coronary artery bypass graft surgery

排除标准

  • Surgery during washout period (October 1st, 2013 - January 31st, 2014)
  • Resurgery
  • Endocarditis
  • Known immunosuppression:
  • Corticosteroid therapy
  • Solid organ transplant
  • Stem Cell therapy
  • HIV diagnosis

研究组 & 干预措施

Etomidate-Time-Frame

Patients that underwent cardiac surgery between October 1st, 2012 and September 30th, 2013

干预措施: Etomidate vs Propofol as induction agent (Drug)

Propofol-Time-Frame

Patients that underwent cardiac surgery between February 1st, 2014 and January 31st, 2015

干预措施: Etomidate vs Propofol as induction agent (Drug)

结局指标

主要结局

Sepsis

时间窗: surgical intervention to hospital discharge, average 30 days

Incidence of sepsis according to diagnosis-related group coding between surgical intervention and hospital discharge (according to SEPSIS II)

次要结局

  • Surgical Site Infections(surgical intervention to hospital discharge, average 30 days)
  • ICU Mortality(surgical intervention to ICU discharge, average 30 days)
  • Pneumonia(surgical intervention to hospital discharge, average 30 days)
  • Mediastinitis(surgical intervention to hospital discharge, average 30 days)
  • Hospital mortality(surgical intervention to hospital discharge, average 30 days)
  • Intensive Care Unit length of stay(ICU admission to ICU discharge, average 30 days)
  • Hospital length of stay(hospital admission to hospital discharge, average 30 days)

研究者

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

Felix Balzer

Prof. Dr. Dr. Felix Balzer, MSc; ECDF-Professor for

Charite University, Berlin, Germany

研究点 (1)

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