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Completed

NCT Number: NCT00415701

Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

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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Key information

Conditions

Coronary Artery Disease Addison Disease Adrenal Gland Diseases Adrenal Insufficiency Arterial Occlusive Diseases Arteriosclerosis Autoimmune Diseases Cardiovascular Diseases Coronary Disease Endocrine System Diseases Heart Diseases Heart Valve Diseases Immune System Diseases Mitral Valve Insufficiency Mitral Valve Regurgitation Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Departments of Intensive Care Medicine and Anesthesiology

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etomidate

Drug

Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Effect of an Anesthetic Induction Dose of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 25, 2006
Registry last updated
Mar 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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