Trials / Unknown
UnknownNCT00006270
Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 32 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 20 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cosyntropin | |
| DRUG | metyrapone |
Timeline
- Start date
- 1998-02-01
- First posted
- 2000-09-12
- Last updated
- 2005-06-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00006270. Inclusion in this directory is not an endorsement.