Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery - Full Text View

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00415701

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease Mitral Valve Regurgitation	Drug: Etomidate Drug: Propofol Drug: Hydrocortisone Drug: NaCl 0.9% Drug: Tetracosactin	Phase IV

MedlinePlus related topics: Anesthesia Coronary Artery Disease Heart Surgery

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Propofol Cosyntropin Etomidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

Incidence of absolute and relative adrenal insufficiency
Cumulative requirements of vasoactive drugs in OR and ICU

Secondary Outcome Measures:

Incidence of failure to wean off cardiopulmonary bypass on first intention
Serum lactate
Time to extubation
Length of stay in ICU, IMC, and hospital
Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery

Estimated Enrollment:	130
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415701

Contacts

Contact: Stephan M Jakob, Professor	+41316323938	stephan.jakob@insel.ch
Contact: Balthasar Eberle, Assoc. Professor	+416328412	balthasar.eberle@insel.ch

Locations

Switzerland, BE
Departments of Intensive Care Medicine and Anesthesiology	Recruiting
Bern, BE, Switzerland, 3010
Contact: Reto M Basciani, MD +41316321902 reto.basciani@insel.ch
Contact: Lukas J Brander, MD +41316320164 lukas.brander@insel.ch
Principal Investigator: Stephan M Jakob, Prof
Sub-Investigator: Balthasar Eberle, Assoc. Prof.
Sub-Investigator: Lukas J Brander, MD
Sub-Investigator: Reto M Basciani, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator:

Stephan M Jakob, Professor

University Hospital Inselspital, Berne

More Information

Publications:

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. Epub 2005 Feb 10.

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.

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. Epub 2005 Jun 28.

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.

Annane D. ICU physicians should abandon the use of etomidate! Intensive Care Med. 2005 Mar;31(3):325-6. Epub 2005 Jan 27. No abstract available.

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.

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.

Fellows IW, Byrne AJ, Allison SP. Adrenocortical suppression with etomidate. Lancet. 1983 Jul 2;2(8340):54-5. No abstract available.

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.

Allolio B, Stuttmann R, Fischer H, Leonhard W, Winkelmann W. Long-term etomidate and adrenocortical suppression. Lancet. 1983 Sep 10;2(8350):626. No abstract available.

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.

Watt I, Ledingham IM. Mortality amongst multiple trauma patients admitted to an intensive therapy unit. Anaesthesia. 1984 Oct;39(10):973-81.

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.

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.

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):1792-8.

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.

Study ID Numbers:	DINA-KEK7406-IBAN-2006-1
Study First Received:	December 22, 2006
Last Updated:	July 31, 2007
ClinicalTrials.gov Identifier:	NCT00415701
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Hydrocortisone
Heart Diseases
Cortisol succinate
Myocardial Ischemia
Vascular Diseases
Cosyntropin
Ischemia

Arteriosclerosis
Etomidate
Heart Valve Diseases
Coronary Disease
Hydrocortisone acetate
Propofol
Coronary Artery Disease
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anti-Inflammatory Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Depressants
Anesthetics
Hormones

Pharmacologic Actions
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Cardiovascular Diseases
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009