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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006270
First received: September 11, 2000
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  Purpose

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 Intervention
Brain Injury
Craniocerebral Trauma
 Drug: cosyntropin
Drug: metyrapone

Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 32
Study Start Date: February 1998
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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006270

Locations
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
Investigators
Study Chair: Randall Urban University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006270     History of Changes
Other Study ID Numbers: 199/15376, UTMB-98-018, UTMB-GCRC-486
Study First Received: September 11, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Adrenocorticotropic Hormone
Cosyntropin
Beta-Endorphin
 Metyrapone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013