Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

NCT00005890 | Completed

• 2 other identifiers: NCRR-M01RR08084-0043CHMC-C-96-3-5
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Keywords

immunologic disorders and infectious disorders; rare disease; sepsis; septic shock

Interventions

corticotropin DRUG

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

MeSH Terms

Conditions

Shock, Septic; Immune System Diseases; Communicable Diseases; Rare Diseases; Sepsis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Richard J. Brilli

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: June 5, 2000
• Study Start: March 1, 1996
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)