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Clinical Trials/NCT00415701
NCT00415701CompletedPhase 4

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country130 target enrollmentStarted: November 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
130
Locations
1
Primary Endpoint
Incidence of absolute and relative adrenal insufficiency

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

1

Experimental

Etomidate as a single induction dose

Intervention: Etomidate (Drug)

2

Active Comparator

Propofol as a single induction dose

Intervention: Propofol (Drug)

3

Other

Hydrocortisone substitution or placebo (50-50%) in etomidate-group

Intervention: Hydrocortisone (Drug)

3

Other

Hydrocortisone substitution or placebo (50-50%) in etomidate-group

Intervention: NaCl 0.9% (Drug)

3

Other

Hydrocortisone substitution or placebo (50-50%) in etomidate-group

Intervention: Tetracosactin (Other)

Outcomes

Primary Outcomes

Incidence of absolute and relative adrenal insufficiency

Time Frame: Preoperative day to postoperative day (POD) 4

Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)

Time Frame: Induction of anesthesia to POD 2

Secondary Outcomes

  • Association of results with preoperative risk, stress-dose hydrocortisone replacement, type of surgery(30 days)
  • Incidence of failure to wean off cardiopulmonary bypass on first intention(intraoperatively)
  • Serum lactate(Induction of anesthesia to discharge ICU)
  • Time to extubation(Induction of anesthesia to extubation)
  • Length of stay (LOS) in the intensive care unit (ICU), intermediate care unit (IMC), and hospital(Admission to discharge: ICU, IMC, and hospital)

Investigators

Study Sites (1)

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