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Completed

NCT Number: NCT00862381

Hydrocortisone Use After Etomidate in Intensive Care

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

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Réanimation polyvalente déchocage, centre hospitalier de la région Annecienne, Annecy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

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

Placebo

Drug

NaCl 0.9%

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2009
Registry last updated
Jul 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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