Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

corticotropin

About this trial

This is an interventional diagnostic trial for Septic Shock focused on measuring immunologic disorders and infectious disorders, rare disease, sepsis, septic shock

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital Medical Center - Cincinnati

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00005890

First Posted

June 2, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Children's Hospital Medical Center, Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT00005890

Brief Title

Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Completed

Study Start Date

March 1996 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Children's Hospital Medical Center, Cincinnati

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Enrollment

56 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

corticotropin

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard J. Brilli

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Study Chair

Facility Information:

Facility Name

Children's Hospital Medical Center - Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229-3039

Country

United States

Septic Shock

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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