Status:
COMPLETED
Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Coronary Artery Disease
Mitral Valve Regurgitation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 respon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00415701
Start Date
November 1 2006
End Date
December 1 2009
Last Update
March 4 2010
Active Locations (1)
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1
Departments of Intensive Care Medicine and Anesthesiology
Bern, Canton of Bern, Switzerland, 3010