Low-dose Hydrocortisone in Acutely Burned Patients

Condition(s) targeted: Burns

Intervention: hydrocortisone 200 mg/day (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Sylvie TISSOT, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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.

Official title: Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients

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

Primary outcome: Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock

Secondary outcome:

Duration of catecholamine administration

Doses of administered catecholamine

Adrenal insufficiency incidence

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Sylvie TISSOT, Lyon 69437, France

Starting date: April 2005
Last updated: February 11, 2015