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NCT Number: NCT00451776

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University hospital

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etomidate

Drug

patients who received etomidate

Propofol

Drug

patients who received propofol

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 23, 2007
Registry last updated
Oct 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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