Hydrocortisone Use After Etomidate in Intensive Care

Study Overview
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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

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.

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

Conditions
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Patient Admitted in Reanimation

Intervention / Treatment
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* Drug: Hydrocortisone
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Hydrocortisone | Drug: Hydrocortisone<br>* hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* NaCl 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diminution of 50% of the proportion of patients with a score SOFA of 3 or 4 |  | 12h, 24h and 48h after the injection of hydrocortisone | 
| mean arterial blood pressure |  | during the hospitalisation | 
| plasmatic cortisol and substance S before and after ACTH stimulation |  | h-4; h6; h12 and h24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical state |  | 12h and 24h | 
| hospitalisation duration in reanimation |  | until day28 | 
| duration of mechanical ventilation |  | until day28 | 
| duration and posology of adrenaline and noradrenaline |  | h0, h4, h6, h12, h24 and h48 | 
| complications during hospitalization in reanimation potentially due to HSHC |  | until day28 | 
| dose of etomidate injection |  | h0 | 
| mortality |  | day28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shock, Tracheal Intubation, reanimation, suprarenal insufficiency, Etomidate, Adrenocorticotropic Hormone, hydrocortisone