Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415701
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : March 4, 2010
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Mitral Valve Regurgitation Drug: Etomidate Drug: Propofol Drug: Hydrocortisone Drug: NaCl 0.9% Other: Tetracosactin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Study Start Date : November 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Etomidate
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Etomidate as a single induction dose
Drug: Etomidate
Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg
Active Comparator: 2
Propofol as a single induction dose
Drug: Propofol
Single induction dose of propofol 2%; total dose 1.5 mg/kg
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
Drug: Hydrocortisone
Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x
Drug: NaCl 0.9%
NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x
Other: Tetracosactin
Diagnostic test, Tetracosactin 250 microg iv

Primary Outcome Measures :
  1. Incidence of absolute and relative adrenal insufficiency [ Time Frame: Preoperative day to postoperative day (POD) 4 ]
  2. Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU) [ Time Frame: Induction of anesthesia to POD 2 ]

Secondary Outcome Measures :
  1. Incidence of failure to wean off cardiopulmonary bypass on first intention [ Time Frame: intraoperatively ]
  2. Serum lactate [ Time Frame: Induction of anesthesia to discharge ICU ]
  3. Time to extubation [ Time Frame: Induction of anesthesia to extubation ]
  4. Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital [ Time Frame: Admission to discharge: ICU, IMC, and hospital ]
  5. Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415701

Departments of Intensive Care Medicine and Anesthesiology
Bern, BE, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Principal Investigator: Stephan M Jakob, Professor University Hospital Inselspital, Berne


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stefan M Jakob, Professor, Department of Critical Care Medicine Identifier: NCT00415701     History of Changes
Other Study ID Numbers: DINA-KEK7406-IBAN-2006-1
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: March 4, 2010
Last Verified: March 2010

Keywords provided by University Hospital Inselspital, Berne:
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists