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OpenTrials
Completed

NCT Number: NCT00149123

Low-dose Hydrocortisone in Acutely Burned Patients

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.

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Key information

Conditions

Burns Adrenal Gland Diseases Adrenal Insufficiency Endocrine System Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sylvie TISSOT

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydrocortisone 200 mg/day

Drug

Primary outcomes

  1. Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock

Secondary outcomes

  1. Duration of catecholamine administration

  2. Doses of administered catecholamine

  3. Adrenal insufficiency incidence

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2005
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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