Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC
Information source: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery
Intervention: etomidate (Drug); propofol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Centre Hospitalier Universitaire de Saint Etienne Official(s) and/or principal investigator(s): Jérome MOREL, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Saint Etienne
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.
Clinical Details
Official title: Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC. A Prospective, Monocentric, Randomised Double Blind Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Time to discharge to vasoactive supportive therapy in the first 48 post operative hours .
Secondary outcome: Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time .Systematic inflammatory response intensity Hemodynamic supportive drugs consumption in patients with SIRS sub group Myocardial infarction incidence in the first 48 postoperative hours . In hospital mortality
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University hospital, Saint-Etienne 42055, France
Additional Information
Starting date: June 2007
Last updated: October 29, 2008
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