Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery

Phase 4

Completed

• Conditions: Coronary Artery Disease; Mitral Valve Regurgitation
• Interventions: Drug: Etomidate; Drug: Propofol; Drug: Hydrocortisone; Drug: NaCl 0.9%; Other: Tetracosactin

• Registration Number: NCT00415701
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-22
• Study First Posted: 2006-12-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-03
• Last Update Posted: 2010-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	NaCl 0.9%	Hydrocortisone substitution or placebo (50-50%) in etomidate-group
3	Tetracosactin	Hydrocortisone substitution or placebo (50-50%) in etomidate-group
1	Etomidate	Etomidate as a single induction dose
2	Propofol	Propofol as a single induction dose
3	Hydrocortisone	Hydrocortisone substitution or placebo (50-50%) in etomidate-group

Primary Outcome Measures

Name	Time	Method
Incidence of absolute and relative adrenal insufficiency	Preoperative day to postoperative day (POD) 4
Cumulative requirements of vasoactive drugs during surgery and in the intensive care unit (ICU)	Induction of anesthesia to POD 2

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Departments of Intensive Care Medicine and Anesthesiology; 🇨🇭 Bern, BE, Switzerland