Study of the Approximate Entropy of Adrenocorticotropic Hormone and Cortisol Secretion in Patients With Head Injury

Brain Injury Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006270
• Other study ID #: 199/15376
• Secondary ID: UTMB-98-018UTMB-
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2000
• Last updated: June 23, 2005
• Start date: February 1998

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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:

• No hypopituitarism

• No body mass index of 28 or greater

• Not pregnant or nursing

• Must have normal menstrual cycles

• No severe mental impairment

• Must not require legal guardian

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Craniocerebral Trauma

Intervention

Drug:
• cosyntropin

• metyrapone

Locations

Country	Name	City	State
United States	Transitional Learning Community	Galveston	Texas
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Texas

Country where clinical trial is conducted

United States,