Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon

Overview

Previous study showed that afternoon cosyntropin testing was associated with a sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a short 2.5 cm tube.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2018

Detailed Description

In earlier studies investigators claimed that subnormal cortisol response using plastic tubes might result from cosyntropin adherence to the tube and loss of the delivered dosage. It was shown that 21.6-58.6% of ACTH dosage had not been recovered when pushed through 20.3 cm plastic tube, and loss of ACTH may be up to 70% when cosyntropin was delivered through a plastic 30 cm scalp vein set. Moreover, it was previously shown that afternoon cosyntropin testing was associated with a sevenfold increased likelihood of failing the 1μg test. However, in that study, investigators used a 20.3 cm plastic tube, which might have led to uncompleted cosyntropin delivery. In ther current study investigators will study afternoon 1μg cosyntropin cortisol stimulation using a short 2.5 cm tube.

Interventions

  • Diagnostic Test: low-dose cosyntropin stimulation test
    • Each subject recruited in the study will undergo low dose cosyntropin stimulation test via intravenous short 2.5 cm plastic tube. 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). For each subject, serum and salivary cortisol will be measured just before cosyntropin administration and 30 minutes later.

Arms, Groups and Cohorts

  • Experimental: healthy subjects
    • 20 healthy subjects will undergo low dose cosyntropin stimulation test. Serum and salivary cortisol will be measured just before cosyntropin administration and 30 minutes later.

Clinical Trial Outcome Measures

Primary Measures

  • Blood cortisol
    • Time Frame: one day
    • Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.

Secondary Measures

  • Salivary free cortisol
    • Time Frame: one day
    • Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.

Participating in This Clinical Trial

Inclusion Criteria

healthy volunteers Exclusion Criteria:

Clinical suspicion of hypoadrenalism Medical condition or treatment that might alter blood cortisol levels Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bnai Zion Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: leonard.saiegh, MD – Bnai Zion Medical Center
  • Overall Official(s)
    • Leonard Saiegh, Principal Investigator, Bni-Zion medical center

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