This trial is active, not recruiting.

Conditions brain injury, craniocerebral trauma
Treatments cosyntropin, metyrapone
Sponsor National Center for Research Resources (NCRR)
Collaborator University of Texas
Start date February 1998
Trial size 32 participants
Trial identifier NCT00006270, 199/15376, UTMB-98-018, UTMB-GCRC-486


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose screening

Eligibility Criteria

Male or female participants from 20 years up to 35 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by National Center for Research Resources (NCRR).