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Hydrocortisone Use After Etomidate in Intensive Care

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ClinicalTrials.gov Identifier: NCT00862381
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : July 26, 2010
Sponsor:
Information provided by:
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

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 Type : Interventional  (Clinical Trial)
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 : October 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010


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%



Primary Outcome Measures :
  1. 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 ]
  2. mean arterial blood pressure [ Time Frame: during the hospitalisation ]
  3. plasmatic cortisol and substance S before and after ACTH stimulation [ Time Frame: h-4; h6; h12 and h24 ]

Secondary Outcome Measures :
  1. clinical state [ Time Frame: 12h and 24h ]
  2. hospitalisation duration in reanimation [ Time Frame: until day28 ]
  3. duration of mechanical ventilation [ Time Frame: until day28 ]
  4. duration and posology of adrenaline and noradrenaline [ Time Frame: h0, h4, h6, h12, h24 and h48 ]
  5. complications during hospitalization in reanimation potentially due to HSHC [ Time Frame: until day28 ]
  6. dose of etomidate injection [ Time Frame: h0 ]
  7. mortality [ Time Frame: day28 ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Registry Identifier: ID RCB )
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: July 26, 2010
Last Verified: July 2010

Keywords provided by University Hospital, Grenoble:
shock
Tracheal Intubation
reanimation
suprarenal insufficiency
Etomidate
Adrenocorticotropic Hormone
hydrocortisone

Additional relevant MeSH terms:
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Etomidate
Anti-Inflammatory Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics