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Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock
This study has been completed.
Study NCT00005890   Information provided by National Center for Research Resources (NCRR)
First Received: June 2, 2000   Last Updated: June 23, 2005   History of Changes

June 2, 2000
June 23, 2005
March 1996
 
 
 
Complete list of historical versions of study NCT00005890 on ClinicalTrials.gov Archive Site
 
 
 
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock
 

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.

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.

 
Interventional
Diagnostic
Septic Shock
Drug: corticotropin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
56
 
 

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

Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005890
 
NCRR-M01RR08084-0043, CHMC-C-96-3-5
National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
Study Chair: Richard J. Brilli Children's Hospital Medical Center, Cincinnati
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP