Hydrocortisone Use After Etomidate in Intensive Care
Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patient Admitted in Reanimation
Intervention: Hydrocortisone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital, Grenoble Official(s) and/or principal investigator(s): Christophe PH, BROUX, Principal Investigator, Affiliation: University Hospital of Grenoble, France
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
Clinical Details
Official title: Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: diminution of 50% of the proportion of patients with a score SOFA of 3 or 4mean arterial blood pressure plasmatic cortisol and substance S before and after ACTH stimulation
Secondary outcome: clinical statehospitalisation duration in reanimation duration of mechanical ventilation duration and posology of adrenaline and noradrenaline complications during hospitalization in reanimation potentially due to HSHC dose of etomidate injection mortality
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
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
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 Ã 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
Locations and Contacts
Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne, Annecy, France
Pôle d'anesthésie - réanimation, University Hospital of Grenoble, Grenoble, France
Additional Information
Starting date: October 2008
Last updated: July 23, 2010
|