ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00005890
  Purpose

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.


Condition Intervention
Septic Shock
Drug: corticotropin

ChemIDplus related topics:   Epinephrine    Epinephrine bitartrate    Corticotropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:   56
Study Start Date:   March 1996

Detailed 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.

  Eligibility
Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005890

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

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Children's Hospital Medical Center, Cincinnati

Investigators
Study Chair:     Richard J. Brilli     Children's Hospital Medical Center, Cincinnati    
  More Information


Study ID Numbers:   NCRR-M01RR08084-0043, CHMC-C-96-3-5
First Received:   June 2, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005890
Health Authority:   United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
immunologic disorders and infectious disorders  
rare disease  
sepsis  
septic shock  

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Rare Diseases
Epinephrine
Adrenocorticotropic Hormone
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers