Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

  • Study Chair: Richard J. Brilli, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1996

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

June 2, 2000

First Posted (Estimate)

June 5, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR08084-0043
  • CHMC-C-96-3-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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