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
Overview
- Phase
- Phase 3
- Intervention
- Hydrocortisone
- Conditions
- Severe Sepsis
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 380
- Locations
- 30
- Primary Endpoint
- Septic shock
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Didier Keh
MD
Charite University, Berlin, Germany
Eligibility Criteria
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
Arms & Interventions
Hydrocortisone
Intervention: Hydrocortisone
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Septic shock
Time Frame: 14 days
Secondary Outcomes
- Immune response to hydrocortisone(6 days)
- Adrenal function(baseline)
- Mortality(28, 90, and 180 days; ICU and hospital)
- Length of stay(ICU and hospital (3-6 months))
- Time to death(28, 90, and 180 days)
- Time to septic shock(14 days)
- Mechanical ventilation(until ICU discharge)
- Renal replacement therapy(until ICU discharge)
- Other adverse events(28 days)
- Posttraumatic stress disorder / health-related quality of life(Hosptal discharge and 180 days after hospital discharge)
- Organ dysfunction (SOFA score)(until ICU discharge but day 14 at maximum)
- Frequency of weaning failure(until ICU discharge)
- Frequency and severity of muscle weakness(until ICU discharge)
- Frequency of gastrointestinal bleeding(28 days)
- Frequency of secondary infections(28 days)
- Delir(ICU discharge)
- Hypernatremia(14 days)
- Hyperglycemia(14 days)