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Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury



Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury

For Condition: Craniocerebral Trauma,Brain Injury
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , University of Texas
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Observational, Screening
Minimum Age/Maximum Age: 20 Years/35 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 32

Location and Contact Information:

Overall Study Official:
RandallUrban,  Study Chair,  University of Texas

Transitional Learning Community *Recruiting*
Galveston,  Texas,  77550
United States
Recruiting Brent  Masel 409-762-6661

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0209
United States
Recruiting Randall  Urban 409-772-1176


Additional Information:
Study ID Numbers:
  199/15376;  UTMB-98-018,UTMB-GCRC-486
Study Start Date: February 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006270

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