Hydrocortisone Use After Etomidate in Intensive Care - Full Text View

Sponsor:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00862381

Purpose

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	Intervention	Phase
Patient Admitted in Reanimation	Drug: Hydrocortisone Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Opothérapie Par Hydrocortisone après Injection Unique d'Etomidate Chez le Patient de réanimation

Resource links provided by NLM:

Drug Information available for: Hydrocortisone acetate Hydrocortisone Etomidate Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

diminution of 50% of the proportion of patients with a score SOFA of 3 or 4 [ Time Frame: 12h, 24h and 48h after the injection of hydrocortisone ] [ Designated as safety issue: No ]
mean arterial blood pressure [ Time Frame: during the hospitalisation ] [ Designated as safety issue: Yes ]
plasmatic cortisol and substance S before and after ACTH stimulation [ Time Frame: h-4; h6; h12 and h24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical state [ Time Frame: 12h and 24h ] [ Designated as safety issue: Yes ]
hospitalisation duration in reanimation [ Time Frame: until day28 ] [ Designated as safety issue: No ]
duration of mechanical ventilation [ Time Frame: until day28 ] [ Designated as safety issue: No ]
duration and posology of adrenaline and noradrenaline [ Time Frame: h0, h4, h6, h12, h24 and h48 ] [ Designated as safety issue: No ]
complications during hospitalization in reanimation potentially due to HSHC [ Time Frame: until day28 ] [ Designated as safety issue: Yes ]
dose of etomidate injection [ Time Frame: h0 ] [ Designated as safety issue: No ]
mortality [ Time Frame: day28 ] [ Designated as safety issue: Yes ]

Enrollment:	106
Study Start Date:	October 2008
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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%

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

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862381

Locations

France
Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne
Annecy, France
Pôle d'anesthésie - réanimation, University Hospital of Grenoble
Grenoble, France

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator:

Christophe PH, BROUX

University Hospital of Grenoble, France

More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr Christophe BROUX, Pôle Anesthésie-Réanimation - CHU de Grenoble
ClinicalTrials.gov Identifier:	NCT00862381 History of Changes
Other Study ID Numbers:	0726, 2007-007603-32
Study First Received:	March 13, 2009
Last Updated:	July 23, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

shock
Tracheal Intubation
reanimation
suprarenal insufficiency

Etomidate
Adrenocorticotropic Hormone
hydrocortisone

Additional relevant MeSH terms:

Adrenocorticotropic Hormone
Etomidate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012