Status:
WITHDRAWN
Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis
Lead Sponsor:
CAMC Health System
Conditions:
Sepsis
Adrenal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Sepsis is a significant cause of morbidity and mortality in critically ill patients in the United States. As evidenced by its increasing prevalence and high mortality rates, sepsis is a complex and di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00368381
Start Date
September 1 2006
End Date
September 1 2009
Last Update
February 13 2012
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