Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
Primary Purpose
Brain Injury, Craniocerebral Trauma
Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
cosyntropin
metyrapone
Sponsored by
About this trial
This is an observational trial for Brain Injury focused on measuring brain injury, neurologic and psychiatric disorders, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients who have sustained head injury Closed head injury from trauma OR Vascular accidents like strokes and hemorrhages --Prior/Concurrent Therapy-- Endocrine therapy: No concurrent cortisol replacement Other: No blood donation during and for 1 month after study --Patient Characteristics-- Hematopoietic: Hemoglobin normal Other: No hypopituitarism No body mass index of 28 or greater Not pregnant or nursing Must have normal menstrual cycles No severe mental impairment Must not require legal guardian
Sites / Locations
- Transitional Learning Community
- University of Texas Medical Branch
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006270
First Posted
September 11, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00006270
Brief Title
Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
Study Type
Observational
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
February 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas
4. Oversight
5. Study Description
Brief Summary
OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury.
II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.
Detailed Description
PROTOCOL OUTLINE: Patients are stratified according to type of injury (closed head injury due to trauma vs vascular accidents). Patients are admitted two times for overnight assessment.
Admission 1: Patients receive cosyntropin IV. Blood is drawn at 30 and 60 minutes after IV infusion. Patients receive oral metyrapone before sleep. A sham sleep study is conducted through the night and patients' blood is drawn in the morning.
Admission 2: At least 2 weeks after admission 1, patients return for an overnight admission. Starting in the evening, blood is drawn every 15 minutes for 12 hours. A sleep study is conducted through the night.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Craniocerebral Trauma
Keywords
brain injury, neurologic and psychiatric disorders, rare disease
7. Study Design
Enrollment
32 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cosyntropin
Intervention Type
Drug
Intervention Name(s)
metyrapone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients who have sustained head injury
Closed head injury from trauma OR
Vascular accidents like strokes and hemorrhages
--Prior/Concurrent Therapy--
Endocrine therapy: No concurrent cortisol replacement
Other: No blood donation during and for 1 month after study
--Patient Characteristics--
Hematopoietic: Hemoglobin normal
Other:
No hypopituitarism
No body mass index of 28 or greater
Not pregnant or nursing
Must have normal menstrual cycles
No severe mental impairment
Must not require legal guardian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Urban
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
Transitional Learning Community
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
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