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Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00415701
First received: December 22, 2006
Last updated: March 3, 2010
Last verified: March 2010
  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%
Other: Tetracosactin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of absolute and relative adrenal insufficiency [ Time Frame: Preoperative day to postoperative day (POD) 4 ] [ Designated as safety issue: No ]
  • Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU) [ Time Frame: Induction of anesthesia to POD 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of failure to wean off cardiopulmonary bypass on first intention [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
  • Serum lactate [ Time Frame: Induction of anesthesia to discharge ICU ] [ Designated as safety issue: No ]
  • Time to extubation [ Time Frame: Induction of anesthesia to extubation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: November 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
3
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

  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
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, see Learn About Clinical Studies.

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

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

Publications:

Responsible Party: Stefan M Jakob, Professor, Department of Critical Care Medicine
ClinicalTrials.gov Identifier: NCT00415701     History of Changes
Other Study ID Numbers: DINA-KEK7406-IBAN-2006-1
Study First Received: December 22, 2006
Last Updated: March 3, 2010
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

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

ClinicalTrials.gov processed this record on November 20, 2014