Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UTMB-98-018 | |||
| UTMB-GCRC-486 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Texas | OTHER |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cosyntropin | Drug | |||
| metyrapone | Drug |
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randall Urban | University of Texas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transitional Learning Community | Galveston | Texas | 77550 | United States | ||
| University of Texas Medical Branch |
Not provided
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D003366 | Cosyntropin |
| D008797 | Metyrapone |
| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
Not provided
Not provided
| Galveston |
| Texas |
| 77555-0209 |
| United States |
| D014947 | Wounds and Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |