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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
University of Texas
Information provided by:
National Center for Research Resources (NCRR)

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.

Condition or disease Intervention/treatment
Brain Injury Craniocerebral Trauma Drug: cosyntropin Drug: metyrapone

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.

Study Type : Observational
Enrollment : 32 participants
Primary Purpose: Screening
Study Start Date : February 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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


  • 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

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Texas
Study Chair: Randall Urban University of Texas Identifier: NCT00006270     History of Changes
Other Study ID Numbers: 199/15376
First Posted: September 12, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
brain injury
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors