Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis

• Status: Withdrawn
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the combination of hydrocortisone plus fludrocortisone is more efficacious than hydrocortisone alone in treating adrenal insufficiency in severe sepsis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CAMC Health System
• Treatments: Cortisol succinate; Epinephrine; Epinephryl borate; Fludrocortisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Racepinephrine

Criteria

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.