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| Sponsor: | University Hospital, Grenoble |
|---|---|
| Information provided by: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00862381 |
Purpose
the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate
| Condition | Intervention | Phase |
|---|---|---|
|
Patient Admitted in Reanimation |
Drug: Hydrocortisone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Hydrocortisone
|
Drug: Hydrocortisone
hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment
|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
NaCl 0.9%
|
Etomidate is a hypnotic widely used for patients in intensive care who require rapid induction, because of its short duration of action, its excellent cardiovascular tolerance and maintenance of cerebral perfusion pressure.
For this reason etomidate remains the hypnotic of choice for induction of unstable patients. Other hypnotics currently in existence do not provide adequate safety with a sufficiently predictable and stable effect in this situation. However, it may induce acute adrenal insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from compound S. An observational study conducted at the Grenoble University hospital in 2006 showed that the duration of this blockage can reach up to 48 hours. Acute adrenal insufficiency in intensive care patients is associated with a poor prognosis. The main objective of this study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate.
This is an interventional, prospective, randomized, placebo-controlled, double-blind, analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who have had tracheal intubation in a pre-hospital or shock treatment setting with the administration of a single injection of etomidate.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Pôle d'anesthésie - réanimation, University Hospital of Grenoble | Recruiting |
| Grenoble, France | |
| Contact: Christophe Broux, Dr CBroux@chu-grenoble.fr | |
| Contact: Clément Dupuis CDupuis1@chu-grenoble.fr | |
| Sub-Investigator: Marc Vinclair, Dr | |
| Sub-Investigator: Jean-François Payen, Pr | |
| Sub-Investigator: Julien Brun, Dr | |
| Sub-Investigator: Claude Jacquot, Pr | |
| Sub-Investigator: Olivier Chabre, Pr | |
| Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne | Enrolling by invitation |
| Annecy, France | |
| Principal Investigator: | Christophe PH, BROUX | University Hospital of Grenoble, France |
More Information
| Responsible Party: | Pôle Anesthésie-Réanimation - CHU de Grenoble ( Dr Christophe BROUX ) |
| Study ID Numbers: | 0726, 2007-007603-32 |
| Study First Received: | March 13, 2009 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00862381 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
shock Tracheal Intubation reanimation suprarenal insufficiency |
Etomidate Adrenocorticotropic Hormone hydrocortisone |
|
Anti-Inflammatory Agents Anesthetics, Intravenous Hydrocortisone Cortisol succinate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anesthetics Central Nervous System Depressants Etomidate |
Hormones Adrenocorticotropic Hormone Pharmacologic Actions Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Hydrocortisone acetate Central Nervous System Agents |