Hydrocortisone Use After Etomidate in Intensive Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Patient Admitted in Reanimation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Hydrocortisone

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl 0.9%

Interventions

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Hydrocortisone

hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment

Intervention Type DRUG

Placebo

NaCl 0.9%

Intervention Type DRUG

Eligibility Criteria

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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 health
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No