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CompletedNCT00451776Updated Oct 31, 2008

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

A Phase 4 interventional study of etomidate and propofol in Cardiac Surgery, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-31.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Surgery

Keywords

  • cardiac surgery
  • adrenal insufficiency
  • etomidate
  • propofol
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    1

    patients who received etomidate

    Drug: etomidate

  • Active comparator
    2

    patients who received propofol

    Drug: propofol

Interventions

  • Drugetomidate

    patients who received etomidate

  • Drugpropofol

    patients who received propofol

06

What researchers measure

Primary outcomes

  1. Time to discharge to vasoactive supportive therapy in the first 48 post operative hours .

    Time frame: 48 hours

Secondary outcomes

  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

07

Study locations

1 site
  • University hospital
    Saint-Etienne, 42055, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00451776
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
First posted
Mar 23, 2007
Start date
Jun 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Oct 31, 2008

Study contacts

Jérome MOREL, MD
principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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