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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451776
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : October 31, 2008
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: etomidate Drug: propofol Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC. A Prospective, Monocentric, Randomised Double Blind Study
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
patients who received etomidate
Drug: etomidate
patients who received etomidate
Active Comparator: 2
patients who received propofol
Drug: propofol
patients who received propofol

Primary Outcome Measures :
  1. Time to discharge to vasoactive supportive therapy in the first 48 post operative hours . [ Time Frame: 48 hours ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451776

University hospital
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator: Jérome MOREL, MD Centre Hospitalier Universitaire de Saint Etienne

Responsible Party: Dr Jérôme MOREL, Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT00451776     History of Changes
Other Study ID Numbers: 0608119
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
cardiac surgery
adrenal insufficiency

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General