Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Incidence of absolute and relative adrenal insufficiency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Etomidate as a single induction dose
Intervention: Etomidate (Drug)
2
Propofol as a single induction dose
Intervention: Propofol (Drug)
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
Intervention: Hydrocortisone (Drug)
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
Intervention: NaCl 0.9% (Drug)
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
Intervention: Tetracosactin (Other)
Outcomes
Primary Outcomes
Incidence of absolute and relative adrenal insufficiency
Time Frame: Preoperative day to postoperative day (POD) 4
Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)
Time Frame: Induction of anesthesia to POD 2
Secondary Outcomes
- 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)