Low-Dose Hydrocortisone in Acutely Burned Patients

This study is currently recruiting participants.

Verified by Hospices Civils de Lyon, October 2007

First Received: September 6, 2005 Last Updated: October 4, 2007 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Burns

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

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

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

Keywords provided by Hospices Civils de Lyon:

Burn
adrenal insufficiency
hydrocortisone
short corticotropin test

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Hydrocortisone
Cortisol succinate

Therapeutic Uses
Hydrocortisone acetate
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010