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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Etomidate as a single induction dose |
|
| 2 | Active Comparator | Propofol as a single induction dose |
|
| 3 | Other | Hydrocortisone substitution or placebo (50-50%) in etomidate-group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etomidate | Drug | Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of failure to wean off cardiopulmonary bypass on first intention | intraoperatively | |
| Serum lactate | Induction of anesthesia to discharge ICU | |
| Time to extubation |
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Inclusion Criteria:
Male or female patients undergoing elective
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan M Jakob, Professor | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Intensive Care Medicine and Anesthesiology | Bern | Canton of Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15703896 | Background | 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. | |
| 16434254 | Background | 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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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D008944 | Mitral Valve Insufficiency |
| D000224 | Addison Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| D015742 | Propofol |
| D006854 | Hydrocortisone |
| D012965 | Sodium Chloride |
| D003366 | Cosyntropin |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Propofol |
| Drug |
Single induction dose of propofol 2%; total dose 1.5 mg/kg |
|
| Hydrocortisone | Drug | Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x |
|
| NaCl 0.9% | Drug | NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x |
|
| Tetracosactin | Other | Diagnostic test, Tetracosactin 250 microg iv |
|
| 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 |
| Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery | 30 days |
| 15985474 | Background | den Brinker M, Joosten KF, Liem O, de Jong FH, Hop WC, Hazelzet JA, van Dijk M, Hokken-Koelega AC. Adrenal insufficiency in meningococcal sepsis: bioavailable cortisol levels and impact of interleukin-6 levels and intubation with etomidate on adrenal function and mortality. J Clin Endocrinol Metab. 2005 Sep;90(9):5110-7. doi: 10.1210/jc.2005-1107. Epub 2005 Jun 28. |
| 10460557 | Background | Absalom A, Pledger D, Kong A. Adrenocortical function in critically ill patients 24 h after a single dose of etomidate. Anaesthesia. 1999 Sep;54(9):861-7. doi: 10.1046/j.1365-2044.1999.01003.x. |
| 15750800 | Background | Annane D. ICU physicians should abandon the use of etomidate! Intensive Care Med. 2005 Mar;31(3):325-6. doi: 10.1007/s00134-005-2560-1. Epub 2005 Jan 27. No abstract available. |
| 2982387 | Background | Duthie DJ, Fraser R, Nimmo WS. Effect of induction of anaesthesia with etomidate on corticosteroid synthesis in man. Br J Anaesth. 1985 Feb;57(2):156-9. doi: 10.1093/bja/57.2.156. |
| 6322902 | Background | Fellows IW, Bastow MD, Byrne AJ, Allison SP. Adrenocortical suppression in multiply injured patients: a complication of etomidate treatment. Br Med J (Clin Res Ed). 1983 Dec 17;287(6408):1835-7. doi: 10.1136/bmj.287.6408.1835. |
| 6134923 | Background | Fellows IW, Byrne AJ, Allison SP. Adrenocortical suppression with etomidate. Lancet. 1983 Jul 2;2(8340):54-5. doi: 10.1016/s0140-6736(83)90043-0. No abstract available. |
| 6325910 | Background | Wagner RL, White PF, Kan PB, Rosenthal MH, Feldman D. Inhibition of adrenal steroidogenesis by the anesthetic etomidate. N Engl J Med. 1984 May 31;310(22):1415-21. doi: 10.1056/NEJM198405313102202. |
| 6136774 | Background | Allolio B, Stuttmann R, Fischer H, Leonhard W, Winkelmann W. Long-term etomidate and adrenocortical suppression. Lancet. 1983 Sep 10;2(8350):626. doi: 10.1016/s0140-6736(83)90710-9. No abstract available. |
| 3261141 | Background | Crozier TA, Beck D, Wuttke W, Kettler D. [Relation of the inhibition of cortisol synthesis in vivo to plasma etomidate concentrations]. Anaesthesist. 1988 May;37(5):337-9. German. |
| 6496912 | Background | Watt I, Ledingham IM. Mortality amongst multiple trauma patients admitted to an intensive therapy unit. Anaesthesia. 1984 Oct;39(10):973-81. doi: 10.1111/j.1365-2044.1984.tb08885.x. |
| 2986663 | Background | Kenyon CJ, McNeil LM, Fraser R. Comparison of the effects of etomidate, thiopentone and propofol on cortisol synthesis. Br J Anaesth. 1985 May;57(5):509-11. doi: 10.1093/bja/57.5.509. |
| 12682474 | Background | 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. |
| 16301260 | Background | Loisa P, Uusaro A, Ruokonen E. A single adrenocorticotropic hormone stimulation test does not reveal adrenal insufficiency in septic shock. Anesth Analg. 2005 Dec;101(6):1792-1798. doi: 10.1213/01.ANE.0000184042.91452.48. |
| 2572134 | Background | Neumann R, Worek FS, Blumel G, Zimmermann GJ, Fehm HL, Pfeiffer UJ. Cortisol deficiency in metomidate anesthetized bacteremic pigs: results in circulatory failure--beneficial effect of cortisol substitution. Acta Anaesthesiol Scand. 1989 Jul;33(5):379-84. doi: 10.1111/j.1399-6576.1989.tb02927.x. |
| 26914224 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006349 | Heart Valve Diseases |
| D000309 | Adrenal Insufficiency |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000324 | Adrenocorticotropic Hormone |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |