Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
NCT ID: NCT00415701
Last Updated: 2010-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
130 participants
INTERVENTIONAL
2006-11-30
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Beta-Blocker Therapy and Phosphodiesterase Inhibition on Cardiac Neurohormonal Activation
NCT00348101
Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy
NCT01631409
Influence of Inotropic Choice on Morbidity and Mortality in Complex Pediatric Heart Surgery
NCT04380181
Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy
NCT05073094
Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic Cardiomyopathy
NCT04133532
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Etomidate as a single induction dose
Etomidate
Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
2
Propofol as a single induction dose
Propofol
Single induction dose of propofol 2%; total dose 1.5 mg/kg
3
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
Hydrocortisone
Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
NaCl 0.9%
NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
Tetracosactin
Diagnostic test, Tetracosactin 250 microg iv
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Etomidate
Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
Propofol
Single induction dose of propofol 2%; total dose 1.5 mg/kg
Hydrocortisone
Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
NaCl 0.9%
NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
Tetracosactin
Diagnostic test, Tetracosactin 250 microg iv
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Department of Critical Care Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephan M Jakob, Professor
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Departments of Intensive Care Medicine and Anesthesiology
Bern, Canton of Bern, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. doi: 10.1111/j.1365-2044.1984.tb08885.x.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DINA-KEK7406-IBAN-2006-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.