Clinical Trial: Value of 25 mcg Cortrosyn Stimulation Test

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis

Brief Summary:

The diagnosis of secondary AI is vital to prevent catastrophic events in patients. An optimal test should have a very low margin of error with high sensitivity and specificity, be easy and safe to administer, and have distinct cut off values. Both 1 ug and 250 ug doses have their limitations. Based on our experience over the past six years, we hypothesize that 25 ug ACTH stimulation test may eliminate some of the shortcomings of the LDST (1 ug) and SDST (250 ug). This is supported by our preliminary data and the study by Oelkers et al, which looked at ACTH levels following various doses of cortrosyn injections.

Therefore we propose a head to head comparison of 25 ug, 250 ug and 1 ug dose using ITT as gold standard.

Detailed Summary:
Sponsor: The Cleveland Clinic

Current Primary Outcome: Peak cortisol values [ Time Frame: 4 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: ACTH level [ Time Frame: 6 hours ]

Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: September 1, 2011
Date Started: September 2011
Date Completion:
Last Updated: November 4, 2015
Last Verified: November 2015