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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-Etienne, France, 42055
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
patients who received etomidate
patients who received etomidate
ACTIVE_COMPARATOR: 2
patients who received propofol
patients who received propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to discharge to vasoactive supportive therapy in the first 48 post operative hours .
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemodynamic supportive drugs ( I .e : dodutamine and noradrenaline ) doses at different time .
Time Frame: several times
several times
Systematic inflammatory response intensity
Time Frame: 6 hours
6 hours
Hemodynamic supportive drugs consumption in patients with SIRS sub group
Time Frame: 24 hours
24 hours
Myocardial infarction incidence in the first 48 postoperative hours .
Time Frame: 48 hours
48 hours
In hospital mortality
Time Frame: day of hospital coming out
day of hospital coming out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jérome MOREL, MD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

March 22, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (ESTIMATE)

March 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 29, 2008

Last Verified

October 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on etomidate

3
Subscribe