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Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock



Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

For Condition: Septic Shock
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Children's Hospital Medical Center - Cincinnati
Synopsis: OBJECTIVES: I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children with septic shock. II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in children with adrenal dysfunction and septic shock.
Details: PROTOCOL OUTLINE: Patients undergo a corticotropin stimulation test within 8 hours of admission to the PICU. Blood samples for plasma cortisol and corticotropin levels are drawn at time 0 followed by corticotropin 1-24 IV. Additional cortisol levels are drawn at 30 and 60 minutes. Corticotropin is measured by immunoradiometric assay and cortisol is measured by radioimmunoassay. Mean arterial blood pressure, heart rate, and respiratory rate are recorded at baseline and at 60 minutes. Patients receive routine management for septic shock and multiple organ system failure.
Eligibility:
Study Type:  Interventional, Diagnostic
Minimum Age/Maximum Age: 1 Month/18 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients admitted to the PICU with septic shock; Hypotension (systolic blood pressure less than 2 standard deviations below age normal) plus 3 or more of the following: temperature greater than 38 or less than 36 degrees Celsius; heart rate greater than 90th percentile for age; respiratory rate greater than 90th percentile for age; WBC greater than 12,000/mm3 or less than 4,000/mm3 or greater than 10% band forms; perfusion abnormalities including lactic acidosis, oliguria, or an acute alteration in mental status Arterial or central venous catheter in place --Prior/Concurrent Therapy-- At least one month since prior corticosteroids --Patient Characteristics-- Renal: No nephrotic syndrome requiring glucocorticoids Pulmonary: No asthma requiring glucocorticoids Other: No condition requiring glucocorticoids (e.g., adrenal insufficiency); No uncontrolled diabetes mellitus; No prior adrenal dysfunction (plasma cortisol concentration less than 19 mcg/dL 30 and 60 minutes post corticotropin stimulation); No hypersensitivity to corticotropin
Total Enrollment: 56

Location and Contact Information:

Overall Study Official:
RichardBrilli,  Study Chair,  Children's Hospital Medical Center - Cincinnati

Children's Hospital Medical Center - Cincinnati
Cincinnati,  Ohio,  45229-3039
United States
 


Additional Information:
Study ID Numbers:  NCRR-M01RR08084-0043;  CHMC-C-96-3-5
Study Start Date: March 1996
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005890

Other Septic Shock Studies:
1. Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

2. Effects of Endotoxin in Normal Human Volunteers

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