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

NCT ID: NCT00451776

Last Updated: 2008-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Surgery

Keywords

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cardiac surgery adrenal insufficiency etomidate propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

patients who received etomidate

Group Type EXPERIMENTAL

etomidate

Intervention Type DRUG

patients who received etomidate

2

patients who received propofol

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

patients who received propofol

Interventions

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etomidate

patients who received etomidate

Intervention Type DRUG

propofol

patients who received propofol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Saint Etienne

Principal Investigators

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Jérome MOREL, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

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University hospital

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2006-007017-21

Identifier Type: -

Identifier Source: secondary_id

0608119

Identifier Type: -

Identifier Source: org_study_id