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Hydrocortisone Use After Etomidate in Intensive Care

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00862381
First received: March 13, 2009
Last updated: July 23, 2010
Last verified: July 2010
History of Changes
  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 3

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:

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):

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
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
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013