Clinical trial NCT00862381: Hydrocortisone Use After Etomidate in Intensive Care
Official title: Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patient Admitted in Reanimation
Keywords: shock
Tracheal Intubation
reanimation
suprarenal insufficiency
Etomidate
Adrenocorticotropic Hormone
hydrocortisone
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 criteria: 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

Primary outcomes:
measure: diminution of 50% of the proportion of patients with a score SOFA of 3 or 4
timeFrame: 12h, 24h and 48h after the injection of hydrocortisone
measure: mean arterial blood pressure
timeFrame: during the hospitalisation
measure: plasmatic cortisol and substance S before and after ACTH stimulation
timeFrame: h-4; h6; h12 and h24
Secondary outcomes:
measure: clinical state
timeFrame: 12h and 24h
measure: hospitalisation duration in reanimation
timeFrame: until day28
measure: duration of mechanical ventilation
timeFrame: until day28
measure: duration and posology of adrenaline and noradrenaline
timeFrame: h0, h4, h6, h12, h24 and h48
measure: complications during hospitalization in reanimation potentially due to HSHC
timeFrame: until day28
measure: dose of etomidate injection
timeFrame: h0
measure: mortality
timeFrame: day28
Other outcomes:
Locations:
city: Annecy
country: France
facility: Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne
city: Grenoble
country: France
facility: Pôle d'anesthésie - réanimation, University Hospital of Grenoble
Study officials:
affiliation: University Hospital of Grenoble, France
name: Christophe PH, BROUX
role: PRINCIPAL_INVESTIGATOR
References:
citation: Payen JF, Dupuis C, Trouve-Buisson T, Vinclair M, Broux C, Bouzat P, Genty C, Monneret D, Faure P, Chabre O, Bosson JL. Corticosteroid after etomidate in critically ill patients: a randomized controlled trial. Crit Care Med. 2012 Jan;40(1):29-35. doi: 10.1097/CCM.0b013e31822d7938.