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Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

I

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed
Phase 4

Conditions

Mitral Valve Regurgitation
Coronary Artery Disease

Treatments

Drug: NaCl 0.9%
Other: Tetracosactin
Drug: Etomidate
Drug: Hydrocortisone
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT00415701
DINA-KEK7406-IBAN-2006-1

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 3 patient groups

1
Experimental group
Description:
Etomidate as a single induction dose
Treatment:
Drug: Etomidate
2
Active Comparator group
Description:
Propofol as a single induction dose
Treatment:
Drug: Propofol
3
Other group
Description:
Hydrocortisone substitution or placebo (50-50%) in etomidate-group
Treatment:
Drug: NaCl 0.9%
Drug: Hydrocortisone
Other: Tetracosactin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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