Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006270
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTMB-GCRC-486 | None | None | None |
| UTMB-98-018 | None | None | None |