Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery (NCT00415701) | Clinical Trial Compass
CompletedPhase 4
Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Switzerland130 participantsStarted 2006-11
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Incidence of absolute and relative adrenal insufficiency
Timeframe: Preoperative day to postoperative day (POD) 4
2
Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)