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Low-Dose Hydrocortisone in Acutely Burned Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00149123
First received: September 6, 2005
Last updated: October 4, 2007
Last verified: October 2007
History of Changes
  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-Blind
Official Title: Low-Dose Hydrocortisone in the Treatment of the Shock of Burned Patients

Resource links provided by NLM:

MedlinePlus related topics: Burns Shock
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00149123     History of Changes
Other Study ID Numbers: 2004.354
Study First Received: September 6, 2005
Last Updated: October 4, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013