drugset / Trial / NCT01284452

Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

NCT01284452

Completed 197 enrolled Mahidol University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Severe sepsis/septic shock is a serious condition associated with high mortality rate. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.

Timeline

Start
2010-12
Primary completion
2014-12
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrocortisone Other / unclassified 50 mg Intravenous