Value of 25 mcg Cortrosyn Stimulation Test (25CST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01428336
First received: September 1, 2011
Last updated: July 30, 2014
Last verified: July 2014

September 1, 2011
July 30, 2014
September 2011
December 2014   (final data collection date for primary outcome measure)
Peak cortisol values [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01428336 on ClinicalTrials.gov Archive Site
ACTH level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Value of 25 mcg Cortrosyn Stimulation Test
The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Adrenal Insufficiency
  • Procedure: ACTH stimulation test
    1 ug cortrosyn dose
  • Procedure: 250 ug ACTH stimulation test
    ACTH stimulation test will be done using 250 ug cortrosyn dose
  • Procedure: 25 ug Cortrosyn stimulation test
    ACTH stimulation test using a 25 ug cortrosyn dose
  • Procedure: Insulin tolerance test
    subjects will undergo an insulin tolerance test
  • Procedure: 1 ug cortrosyn test
    Subjects will undergo an ACTH test using a 1 ug dose cortrosyn
  • Active Comparator: 1ug cortrosyn dose stimulation test
    Subjects will undergo an ACTH stimulation test using a dose of 1 ug cotrosyn
    Interventions:
    • Procedure: ACTH stimulation test
    • Procedure: 1 ug cortrosyn test
  • Active Comparator: 250 ug cortrosyn dose stimulation test
    Subjects will undergo an ACTH stimulation test using 250 ug cortrosyn dose
    Intervention: Procedure: 250 ug ACTH stimulation test
  • Experimental: 25 ug cortrosyn stimulation test
    Subjects will undergo an ACTH stimulation test using a 25 ug cortosyn dose
    Intervention: Procedure: 25 ug Cortrosyn stimulation test
  • Active Comparator: Insulin tolerance test
    Subjects will undergo an Insulin Tolerance Test
    Intervention: Procedure: Insulin tolerance test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • hypothalamic-pituitary-adrenal disorders

Exclusion Criteria:

  • under 18 or older than 65 years of age
Both
18 Years to 65 Years
Yes
Contact: Amir Hamrahian, MD 216-445-8538 hamraha@ccf.org
Contact: Seenia Peechakara, MD 216-445-5411 peechas@ccf.org
United States
 
NCT01428336
1945
Yes
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Not Provided
The Cleveland Clinic
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP