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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Texas |
|---|---|
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006270 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain Injury Craniocerebral Trauma |
Drug: cosyntropin Drug: metyrapone |
| Study Type: | Observational |
| Study Design: | Screening |
| Estimated Enrollment: | 32 |
| Study Start Date: | February 1998 |
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| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, Texas | |
| Transitional Learning Community | |
| Galveston, Texas, United States, 77550 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0209 | |
| Study Chair: | Randall Urban | University of Texas |
More Information
| Study ID Numbers: | 199/15376, UTMB-98-018, UTMB-GCRC-486 |
| Study First Received: | September 11, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006270 History of Changes |
| Health Authority: | United States: Federal Government |
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brain injury neurologic and psychiatric disorders rare disease |
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Antimetabolites Craniocerebral Trauma Hydrocortisone Cortisol succinate Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries Rare Diseases Disorders of Environmental Origin Central Nervous System Diseases |
Cosyntropin Trauma, Nervous System Brain Diseases Hormones Adrenocorticotropic Hormone Metyrapone Mental Disorders Hydrocortisone acetate Brain Injuries |
|
Antimetabolites Craniocerebral Trauma Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Hormones, Hormone Substitutes, and Hormone Antagonists Disorders of Environmental Origin Central Nervous System Diseases |
Enzyme Inhibitors Trauma, Nervous System Cosyntropin Brain Diseases Hormones Pharmacologic Actions Adrenocorticotropic Hormone Metyrapone Brain Injuries |
