Low-dose Hydrocortisone in Acutely Burned Patients

Burns Clinical Trial

Official title:

Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149123
• Other study ID #: 2004.354
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2005
• Last updated: February 11, 2015
• Start date: April 2005
• Est. completion date: October 2010

Study information

• Verified date: October 2007
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• hydrocortisone 200 mg/day

Locations

Country	Name	City	State
France	Sylvie TISSOT	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
Secondary	Duration of catecholamine administration
Secondary	Doses of administered catecholamine
Secondary	Adrenal insufficiency incidence