Coronary Artery Disease, Mitral Valve Regurgitation
Conditions
Keywords
Etomidate, Propofol, Adrenocortical Insufficiency, Hemodynamic Process, Vasoactive Agonists, Coronary Artery Bypass, Ischemic Coronary Heart Disease, Mitral valve reconstruction/replacement, Mitral valve regurgitation, Heart Valve Prosthesis, Cardiopulmonary Bypass
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 responsiveness, on requirements of hemodynamic support, and on use of intensive care resources.
Interventions
DRUGHydrocortisone
Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
DRUGNaCl 0.9%
NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
DRUGEtomidate
Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
DRUGPropofol
Single induction dose of propofol 2%; total dose 1.5 mg/kg
OTHERTetracosactin
Diagnostic test, Tetracosactin 250 microg iv
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of absolute and relative adrenal insufficiency | Preoperative day to postoperative day (POD) 4 |
| Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU) | Induction of anesthesia to POD 2 |
Secondary
| Measure | Time frame |
|---|---|
| Time to extubation | Induction of anesthesia to extubation |
| Incidence of failure to wean off cardiopulmonary bypass on first intention | intraoperatively |
| Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery | 30 days |
| Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital | Admission to discharge: ICU, IMC, and hospital |
| Serum lactate | Induction of anesthesia to discharge ICU |
Countries
Switzerland
Outcome results
None listed