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Hydrocortisone Use After Etomidate in Intensive Care

Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Patient Admitted in Reanimation

Intervention: Hydrocortisone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital, Grenoble

Official(s) and/or principal investigator(s):
Christophe PH, BROUX, Principal Investigator, Affiliation: University Hospital of Grenoble, France


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

Clinical Details

Official title: Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

diminution of 50% of the proportion of patients with a score SOFA of 3 or 4

mean arterial blood pressure

plasmatic cortisol and substance S before and after ACTH stimulation

Secondary outcome:

clinical state

hospitalisation duration in reanimation

duration of mechanical ventilation

duration and posology of adrenaline and noradrenaline

complications during hospitalization in reanimation potentially due to HSHC

dose of etomidate injection


Detailed description: 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.


Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.


Inclusion Criteria:

- Patients who received an unique injection of etomidate in pre-hospital situation or

at "déchocage" in the previous 6 hours.

- informed consent signed by the patient or the reliable person

- affiliation to a regime of social security

Exclusion Criteria:

- persons aimed at the articles L. 1121-5 à L. 1121-8 of the french code of public


- toxic shock requiring a treatment by HSHC inn accordance with the criteria of Annane

et Al. [13]

- purpura fulminans

- chronicle suprarenal insufficiency

- patients likely to present an acute suprarenal insufficiency : current treatment with

antifungal : ketoconazole or fluconazole, known HIV infection, Sheehan syndrome

- corticotherapy in the 6 last months

- initiation of hydrocortisone therapy out of the study

- survival estimated at less than 48 hours

- no benefits of social security

- refusal to participate by patient or reliable person

Locations and Contacts

Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne, Annecy, France

Pôle d'anesthésie - réanimation, University Hospital of Grenoble, Grenoble, France

Additional Information

Starting date: October 2008
Last updated: July 23, 2010

Page last updated: August 23, 2015

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