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NCT00005890 Clinical Trial

Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

Septic Shock Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005890
Other study ID # NCRR-M01RR08084-0043
Secondary ID CHMC-C-96-3-5
Status Completed
Phase N/A
First received June 2, 2000
Last updated June 23, 2005
Start date March 1996

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 18 Years
Eligibility 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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• corticotropin

Locations
Country Name City State
United States Children's Hospital Medical Center - Cincinnati Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

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