Hydrocortisone for Prevention of Septic Shock (HYPRESS)

Charité University Medicine Berlin

Status and phase: Completed; Phase 3

Conditions: Severe Sepsis

Treatments: Drug: Hydrocortisone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00670254

01KG0701 (Other Identifier)

2007-004401-10 (EudraCT Number)

HYPRESS

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

380 participants in 2 patient groups, including a placebo group

Hydrocortisone

Experimental group

Treatment:

Drug: Hydrocortisone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo