Clinical trial NCT00415701: Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Official title: Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Mitral Valve Regurgitation
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
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of absolute and relative adrenal insufficiency
timeFrame: Preoperative day to postoperative day (POD) 4
measure: Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)
timeFrame: Induction of anesthesia to POD 2
Secondary outcomes:
measure: Incidence of failure to wean off cardiopulmonary bypass on first intention
timeFrame: intraoperatively
measure: Serum lactate
timeFrame: Induction of anesthesia to discharge ICU
measure: Time to extubation
timeFrame: Induction of anesthesia to extubation
measure: Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital
timeFrame: Admission to discharge: ICU, IMC, and hospital
measure: Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Departments of Intensive Care Medicine and Anesthesiology
state: BE
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Stephan M Jakob, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malerba G, Romano-Girard F, Cravoisy A, Dousset B, Nace L, Levy B, Bollaert PE. Risk factors of relative adrenocortical deficiency in intensive care patients needing mechanical ventilation. Intensive Care Med. 2005 Mar;31(3):388-92. doi: 10.1007/s00134-004-2550-8. Epub 2005 Feb 10.
citation: Weis F, Kilger E, Roozendaal B, de Quervain DJ, Lamm P, Schmidt M, Schmolz M, Briegel J, Schelling G. Stress doses of hydrocortisone reduce chronic stress symptoms and improve health-related quality of life in high-risk patients after cardiac surgery: a randomized study. J Thorac Cardiovasc Surg. 2006 Feb;131(2):277-82. doi: 10.1016/j.jtcvs.2005.07.063.
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citation: Kilger E, Weis F, Briegel J, Frey L, Goetz AE, Reuter D, Nagy A, Schuetz A, Lamm P, Knoll A, Peter K. Stress doses of hydrocortisone reduce severe systemic inflammatory response syndrome and improve early outcome in a risk group of patients after cardiac surgery. Crit Care Med. 2003 Apr;31(4):1068-74. doi: 10.1097/01.CCM.0000059646.89546.98.
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citation: Basciani RM, Rindlisbacher A, Begert E, Brander L, Jakob SM, Etter R, Carrel T, Eberle B. Anaesthetic induction with etomidate in cardiac surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):417-24. doi: 10.1097/EJA.0000000000000434.