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

Cardiac Surgery Clinical Trial

Official title:

Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC. A Prospective, Monocentric, Randomised Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451776
• Other study ID #: 0608119
• Secondary ID: 2006-007017-21
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2007
• Last updated: October 29, 2008
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

Information will be given at the anaesthetic consultation, few weeks before planed cardiac surgery. Eligibility and exclusion criteria will be checked. Patient will receive an informative written consent notice and all questions will be answered. A standard pre-operative blood collection will be sampled.

In order to minimize the potential confusing effect of daily cortisol variation, only surgical procedure performed early morning will be considered. The day before surgery definitive inclusion will be decided as the order of procedure is not known before. Only patients operated in the morning will be included because of cortisol daily variations. At this time, consent and information notice will be signed and checked in the medical record.

On the morning of surgery, during venous catheter insertion an additional blood sample will be collected to asses basal cortisolemia.

Randomisation will be carried out centrally after patient operative theatre admission, by phone call from ICU to randomisation office. Hypnotic drug will be prepared in the ICU department next to the operative room and blindly administered to patient ( same volume per weight ). All other anesthetic procedures will be standardised : opioid drugs, vasopressive support, antifibrinolytics and hemodynamic monitoring.

After surgery patients are admitted to surgical ICU. They will undergo standard post operative exams plus two corticotrophin tests and a dosage of SIRS markers ( IL6 and TNF alpha ). These results will only be known at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age superior to 18 years

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

Exclusion Criteria:

• patient with aortics shrinking

• women pregnant or nursing

• contra-indication to etomidate or diprivan or synacthene

• patient with insufficiency kidney

• patient with infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• etomidate
patients who received etomidate
• propofol
patients who received propofol

Locations

Country	Name	City	State
France	University hospital	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discharge to vasoactive supportive therapy in the first 48 post operative hours .		48 hours	No
Secondary	Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time .		several times	No
Secondary	Systematic inflammatory response intensity		6 hours	No
Secondary	Hemodynamic supportive drugs consumption in patients with SIRS sub group		24 hours	No
Secondary	Myocardial infarction incidence in the first 48 postoperative hours .		48 hours	Yes
Secondary	In hospital mortality		day of hospital coming out	Yes