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The Utility of Plasma Free Cortisol in the Assessment of Adrenal Function in Patients with Pituitary Disease

The Utility of Plasma Free Cortisol in the Assessment of Adrenal Function in Patients with Pituitary Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000541202
Enrollment
81
Registered
2009-07-06
Start date
2009-03-13
Completion date
2010-11-29
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to determine whether measurement of total and free cortisol by mass spectrometry improves the diagnostic accuracy of synacthen tests to assess adrenal function in patients with pituitary disease.

Interventions

A 250 mcg synacthen test (250 mcg synacthen administered intramuscularly (IM) with cortisol measurements before and 30 and 60 minutes after synacthen) and a 1 mcg synacthen test (1 mcg synacthen administered intravenously (IV) with cortisol measurements before and 30 and 60 minutes after synacthen). These tests will be performed once each to each subject separated by approximately 7 days. The tests will be performed in healthy subjects (to define a normal reference range) and in subjects with pi

A 250 mcg synacthen test (250 mcg synacthen administered intramuscularly (IM) with cortisol measurements before and 30 and 60 minutes after synacthen) and a 1 mcg synacthen test (1 mcg synacthen administered intravenously (IV) with cortisol measurements before and 30 and 60 minutes after synacthen). These tests will be performed once each to each subject separated by approximately 7 days. The tests will be performed in healthy subjects (to define a normal reference range) and in subjects with pituitary disease previously defined as either adrenocorticotrophic hormone (ACTH) sufficient or deficient by current gold standard tests.

Sponsors

Department of Health, South Australia
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Pituitary patients: Clearly diagnosed with either ACTH sufficiency/deficiency Normal volunteers: Age 20-80 yrs

Exclusion criteria

Pregnancy, advanced malignancy, active infection, liver failure

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026