Hydrocortisone for Prevention of Septic Shock

Charite University, Berlin, Germany380 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

380

Conditions

Severe Sepsis

Interventions

PlaceboDRUG

Application is identical to experimental arm

HydrocortisoneDRUG

50 mg loading dose, continuous infusion of 200 mg/d for 5 d, 100 mg/d for 2d, 50 mg/d for 2 d, and 25 mg/d for 2 d.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

Septic shock

Time frame: 14 days

Secondary Outcomes

Mortality

Time frame: 28, 90, and 180 days; ICU and hospital

Length of stay

Time frame: ICU and hospital (3-6 months)

Time to death

Time frame: 28, 90, and 180 days

Time to septic shock

Time frame: 14 days

Mechanical ventilation

Time frame: until ICU discharge

Renal replacement therapy

Time frame: until ICU discharge

Organ dysfunction (SOFA score)

Time frame: until ICU discharge but day 14 at maximum

Frequency of weaning failure

Time frame: until ICU discharge

Frequency and severity of muscle weakness

Time frame: until ICU discharge

Frequency of gastrointestinal bleeding

Time frame: 28 days

Frequency of secondary infections

Time frame: 28 days

Delir

Data from ClinicalTrials.gov

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Helios Klinikum Berlin Buch, Klinik für Intensivmedizin

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Charité Universitaetsmedizin Berlin, Campus Virchow-Klinikum und Campus Mitte, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie

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...and 20 more locations