Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of absolute and relative adrenal insufficiency
研究概览
简要总结
The purpose of this study is to evaluate the effect of a single dose of etomidate for patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB adrenocortical responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients undergoing elective
- •coronary artery bypass graft (primary or re-operation)
- •mitral valve reconstruction/replacement for mitral valve regurgitation
- •Age between 18 and 80 years (extremes included)
- •Subject itself has signed the informed consent
- •No clinically relevant deviation from the laboratory's reference range of biochemistry, hematology, or urinalysis testing
排除标准
- •Participation in another ongoing interventional trial
- •Known adrenocortical insufficiency
- •Use of etomidate or propofol within 1 week preoperatively
- •Use of glucocorticoids within 6 month preoperatively
- •Known sensitivity to etomidate, propofol, or emulgator
- •Severe hepatic dysfunction (bilirubin > 3mg/dl)
- •Severe renal dysfunction (plasma creatinine > 180mikromol/l)
- •Sepsis, endocarditis or other chronic inflammatory disease
- •Manifest insulin-dependent diabetes mellitus
- •Positive HIV serology
- •Hemodynamically significant carotid stenosis requiring treatment
- •Serious illnesses: endocrine, neurological, psychiatric, metabolic disturbances
- •Pregnancy or breast-feeding female; females will be subject to pregnancy testing
- •Requirement of rapid sequence induction
- •Emergency surgery
- •History of asthma
研究组 & 干预措施
1
Etomidate as a single induction dose
干预措施: Etomidate (Drug)
2
Propofol as a single induction dose
干预措施: Propofol (Drug)
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
干预措施: Hydrocortisone (Drug)
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
干预措施: NaCl 0.9% (Drug)
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
干预措施: Tetracosactin (Other)
结局指标
主要结局
Incidence of absolute and relative adrenal insufficiency
时间窗: Preoperative day to postoperative day (POD) 4
Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)
时间窗: Induction of anesthesia to POD 2
次要结局
- Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery(30 days)
- Incidence of failure to wean off cardiopulmonary bypass on first intention(intraoperatively)
- Serum lactate(Induction of anesthesia to discharge ICU)
- Time to extubation(Induction of anesthesia to extubation)
- Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital(Admission to discharge: ICU, IMC, and hospital)