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Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005890
First Posted: June 5, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
National Center for Research Resources (NCRR)
  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

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00005890     History of Changes
Other Study ID Numbers: NCRR-M01RR08084-0043
CHMC-C-96-3-5
First Submitted: June 2, 2000
First Posted: June 5, 2000
Last Update Posted: December 9, 2005
Last Verified: December 2003

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

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs