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Low-dose Hydrocortisone in Acutely Burned Patients

This study has been completed.
Information provided by:
Hospices Civils de Lyon Identifier:
First received: September 6, 2005
Last updated: February 11, 2015
Last verified: October 2007
Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.

Condition Intervention Phase
Burns Drug: hydrocortisone 200 mg/day Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock

Secondary Outcome Measures:
  • Duration of catecholamine administration
  • Doses of administered catecholamine
  • Adrenal insufficiency incidence

Estimated Enrollment: 40
Study Start Date: April 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • males and females,
  • between 18 and 75 year old
  • who present a burned surface more than 30% of the body surface
  • who need catecholamine infusion
  • between J0 and J3 after the injury.

Exclusion Criteria:

  • pregnancy,
  • trauma,
  • sepsis,
  • cardiac insufficiency,
  • AIDS,
  • etomidate administration
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Please refer to this study by its identifier: NCT00149123

Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Sylvie TISSOT, MD Hospices Civils de Lyon
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00149123     History of Changes
Other Study ID Numbers: 2004.354
Study First Received: September 6, 2005
Last Updated: February 11, 2015

Keywords provided by Hospices Civils de Lyon:
adrenal insufficiency
short corticotropin test

Additional relevant MeSH terms:
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents processed this record on August 18, 2017