Hydrocortisone for Prevention of Septic Shock

Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis

Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.

Inclusion Criteria:

• Severe sepsis according to ACCP/CCM criteria
• Onset of severe sepsis < 48 hours
• Informed consent
• Effective contraception in fertile women

Exclusion Criteria:

• Septic shock
• Known hypersensitivity to hydrocortisone and additives
• Glucocorticoid history which warrants continuation of glucocorticoid administration
• Other indication for systemic glucocorticoid therapy
• DNR-order
• Moribund patient
• Pregnancy
• Breast feeding women
• Age < 18 years
• Other interventional study
• Relationship to investigator