Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC - Full Text View

Sponsored by:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00451776

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery	Drug: etomidate Drug: propofol	Phase IV

MedlinePlus related topics: Anesthesia Heart Surgery

Drug Information available for: Propofol Etomidate Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC. A Prospective, Monocentric, Randomised Double Blind Study

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

Time to discharge to vasoactive supportive therapy in the first 48 post operative hours . [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time . [ Time Frame: several times ] [ Designated as safety issue: No ]
Systematic inflammatory response intensity [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Hemodynamic supportive drugs consumption in patients with SIRS sub group [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Myocardial infarction incidence in the first 48 postoperative hours . [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
In hospital mortality [ Time Frame: day of hospital coming out ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	June 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients who received etomidate	Drug: etomidate patients who received etomidate
2: Active Comparator patients who received propofol	Drug: propofol patients who received propofol

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451776

Locations

France
University hospital
Saint-Etienne, France, 42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator:

Jérome MOREL, MD

Centre Hospitalier Universitaire de Saint Etienne

More Information

Responsible Party:	Centre Hospitalier Universitaire de Saint Etienne ( Dr Jérôme MOREL )
Study ID Numbers:	0608119, 2006-007017-21
Study First Received:	March 22, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00451776
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

cardiac surgery
adrenal insufficiency
etomidate
propofol

Study placed in the following topic categories:

Adrenal Insufficiency
Epinephrine
Etomidate

Propofol
Hypoadrenalism
Adrenal gland hypofunction

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives

Anesthetics
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009