Hydrocortisone Use After Etomidate in Intensive Care

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT00862381

Collaborator

(none)

106

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Patient Admitted in Reanimation	Drug: Hydrocortisone Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Hydrocortisone	Drug: Hydrocortisone hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment
Placebo Comparator: 2 Placebo	Drug: Placebo NaCl 0.9%

Arm

Intervention/Treatment

Experimental: 1

Hydrocortisone

Drug: Hydrocortisone

hemisuccinate d'hydrocortisone, 200mg per 24 hours, 48 hours of treatment

Placebo Comparator: 2

Placebo

Drug: Placebo

NaCl 0.9%

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne	Annecy		France
2	Pôle d'anesthésie - réanimation, University Hospital of Grenoble	Grenoble		France