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

N

National Center for Research Resources (NCRR)

Status

Unknown

Conditions

Brain Injury
Craniocerebral Trauma

Treatments

Drug: cosyntropin
Drug: metyrapone

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00006270
199/15376
UTMB-98-018
UTMB-GCRC-486

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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