- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451776
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
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Saint-Etienne, France, 42055
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Jérome MOREL, MD, Centre Hospitalier Universitaire de Saint Etienne
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0608119
- 2006-007017-21
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.
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