Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
This trial is active, not recruiting.
|Conditions||brain injury, craniocerebral trauma|
|Sponsor||National Center for Research Resources (NCRR)|
|Collaborator||University of Texas|
|Start date||February 1998|
|Trial size||32 participants|
|Trial identifier||NCT00006270, 199/15376, UTMB-98-018, UTMB-GCRC-486|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
Male or female participants from 20 years up to 35 years old.
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
|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.|
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