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Low-dose Hydrocortisone in Acutely Burned Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149123
First Posted: September 8, 2005
Last Update Posted: February 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospices Civils de Lyon
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT00149123


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149123     History of Changes
Other Study ID Numbers: 2004.354
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: February 12, 2015
Last Verified: October 2007

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

Additional relevant MeSH terms:
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents