Clinical Research Directory

Inclusion Criteria: * Males and non-pregnant females \> 18 years of age * Patients admitted and/or pending admission to the intensive care unit * Positive corticotropin stimulation test (Basal cortisol level of ≤ 34 μg/dL with Δ ≤ 9 μg/dL after administration of 250 mg of cosyntropin) Patient satisfies criteria for severe sepsis Infection - one or more of the following criteria * Documented or Suspected - positive culture results (from blood, sputum, urine, etc.) * Anti-Infective Therapy - patient is receiving antibiotic, antifungal, or other anti-infective therapy * Pneumonia - documentation of pneumonia (x-ray, etc.) * WBCs - WBCs found in normally sterile .uid (urine, CSF, etc.) * Perforated Viscus - perforation of hollow organ (bowel) SIRS - two or more of the following * Temperature \> 38° or \< 36° * Heart rate \> 90 bpm * Respiratory rate above 20 breaths per minute * WBC \> 14,000/mm3 , \< 4000/mm3, or \>10% Bands Acute organ dysfunction - one or more of the following * Cardiovascular - SBP \< 90 mmHg or MAP \< 70 mmHg despite 20 mL/kg of fluid resuscitation * Respiratory - PaO2/FiO2 ratio \< 250, PEEP \> 7.5, or require mechanical ventilation * Renal - low urine output (eg, \<0.5 mL/kg/hr for 1 hour despite 20mL/kg of fluid resuscitation, increased creatinine (\>50% increase from baseline) or require acute dialysis * Hematologic - low platelet count (\< 100,000/mm3) or PT/PTT \> upper limit of normal * Metabolic - low pH with high lactate (eg, pH \< 7.30 and plasma lactate \> upper limit of normal * Hepatic - liver enzymes \> 2x upper limit of normal * CNS - altered consciousness or reduced Glasgow Coma Score Exclusion Criteria: * Patients who respond to the short cosyntropin stimulation test(Δ \> 9mg/dL) * Pregnancy or breast-feeding mother * Evidence of acute myocardial infarction, meningitis, pulmonary embolism * AIDS (CD4 \< 200 cells/mL) * Contraindications for corticosteroids * Formal indication for corticosteroids (specifically including patients with known adrenal insufficiency) * Onset of shock \> 24 hours * Etomidate administration within the 6 hours preceding randomization * Cardiac arrest prior to randomization.