Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC

NCT00451776 | Completed Phase 4 DMC

• 2 other identifiers: 06081192006-007017-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Because of its hemodynamic safety, etomidate is widely used for anaesthesia induction of cardiac surgery. It can also cause adrenal insufficiency during the following 48 hours ( 11 betahydroxylase inhibition ). So it could increase hemodynamic dysfunction caused by the SIRS following cardiopulmonary bypass. A previous observational study found more adrenal insufficiency and need for vasopressive support therapy in the etomidate group versus another propofol induced group. The aim of our work is to compare hemodynamic dysfunction following induction with etomidate for cardiac surgery with ECC. The control group would be induced by Propofol. 94 patients would be included.

Conditions

Cardiac Surgery

Keywords

cardiac surgery; adrenal insufficiency; etomidate; propofol

Outcome Measures

Primary Outcomes (1)

• Time to discharge to vasoactive supportive therapy in the first 48 post operative hours .

  48 hours

Secondary Outcomes (5)

• Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time .

  several times

• Systematic inflammatory response intensity

  6 hours

• Hemodynamic supportive drugs consumption in patients with SIRS sub group

  24 hours

• Myocardial infarction incidence in the first 48 postoperative hours .

  48 hours

• In hospital mortality

  day of hospital coming out

Study Arms (2)

1

EXPERIMENTAL

patients who received etomidate

Drug: etomidate

2

ACTIVE COMPARATOR

patients who received propofol

Drug: propofol

Interventions

etomidate DRUG

patients who received etomidate

1

propofol DRUG

patients who received propofol

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age superior to 18 years
• patient which had to be operated for aorto-coronary pass and/or valvular replacement

You may not qualify if:

• patient with aortics shrinking
• women pregnant or nursing
• contra-indication to etomidate or diprivan or synacthene
• patient with insufficiency kidney
• patient with infection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

University hospital

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Etomidate; Propofol

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jérome MOREL, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 31, 2008

Record last verified: 2008-10

Locations

FR (1)