Hydrocortisone Use After Etomidate in Intensive Care

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Patient Admitted in Reanimation

Treatments

Drug: Placebo

Drug: Hydrocortisone

Study type

Interventional

Funder types

Other

Identifiers

NCT00862381

2007-007603-32 (Registry Identifier)

0726

Details and patient eligibility

About

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

Full 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.

Enrollment

106 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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