Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
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|ClinicalTrials.gov Identifier: NCT00006270|
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Active, not recruiting
First Posted : September 12, 2000
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment|
|Brain Injury Craniocerebral Trauma||Drug: cosyntropin Drug: metyrapone|
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.
|Study Type :||Observational|
|Estimated Enrollment :||32 participants|
|Study Start Date :||February 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006270
|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|