Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

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

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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