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Low-Dose Hydrocortisone in Acutely Burned Patients
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, October 2007
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00149123
  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 IV

MedlinePlus related topics: Burns
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Corticotropin Epinephrine Epinephrine bitartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: Low-Dose Hydrocortisone in the Treatment of the Shock of Burned Patients

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149123

Contacts
Contact: Sylvie TISSOT, MD 33 4 72 11 75 98 sylvie.tissot@chu-lyon.fr

Locations
France
Sylvie TISSOT Recruiting
Lyon, France, 69437
Contact: Sylvie TISSOT, MD     33 4 72 11 75 98     sylvie.tissot@chu-lyon.fr    
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvie TISSOT, MD Hospices Civils de Lyon
  More Information

Study ID Numbers: 2004.354
Study First Received: September 6, 2005
Last Updated: October 4, 2007
ClinicalTrials.gov Identifier: NCT00149123  
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Burns
Adrenal Insufficiency
Hydrocortisone
Cortisol succinate
Shock
Hydrocortisone acetate
Epinephrine
Hypoadrenalism
Adrenocorticotropic Hormone
Adrenal gland hypofunction

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009