Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Cortisol succinate; Cosyntropin; Etomidate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Propofol

Criteria

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