Hydrocortisone Use After Etomidate in Intensive Care
- Conditions
- Patient Admitted in Reanimation
- Interventions
- Drug: Placebo
- Registration Number
- NCT00862381
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo 1 Hydrocortisone Hydrocortisone
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne
🇫🇷Annecy, France
Pôle d'anesthésie - réanimation, University Hospital of Grenoble
🇫🇷Grenoble, France