Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers

NCT03752190 | Withdrawn Phase 4

• 1 other identifier: IRB00193457
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cosyntropin (synthetic ACTH) stimulation test is considered the optimal test for diagnosis of primary and long-standing secondary adrenal insufficiency. The standard cosyntropin stimulation test is performed by administering 250 µg cosyntropin intravenously. Serum cortisol is measured before, and at 30 and 60 minutes after the bolus injection. Peak cortisol levels below 500 nmol/L (18.1 µg/dL) at 30 or 60 minutes after cosyntropin administration indicate adrenal insufficiency per recent guidelines, without specification of how the cosyntropin is administered (intravenously or intramuscularly). However, the peak stimulated cortisol cutoff value is based on old, fluorometric or radio-immunological methods that are known to detect significant amounts of glucocorticoids other than cortisol. For this reason, peak cortisol levels, as determined by older assays, may set higher thresholds than what might be considered necessary using a newer, more specific assay. The widely-used old Elecsys® Cortisol Immunoassay from Roche Diagnostics (Cortisol I) is now replaced worldwide (including Johns Hopkins Hospital) by a new Elecsys® Cortisol assay from Roche Diagnostics (Cortisol II). The new Cortisol II assay employs a monoclonal as opposed to a polyclonal capturing antibody, which was used in the old Cortisol I assay. This results in greater specificity for cortisol. The new Cortisol II assay was shown to have strong correlation with cortisol levels measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) which is considered the gold standard for cortisol measurement. Previous studies addressing the cortisol cutoff levels for the diagnosis of adrenal insufficiency with different cortisol assays have been heterogeneous in terms of the dose and route of administration of cosyntropin used, and the wide variety of subjects being tested including healthy subjects that are occasionally on oral estrogen therapy and patients with adrenal insufficiency. Many clinical centers use intramuscular cosyntropin injections given its convenience, and as mentioned earlier, many institutions are now using the new Roche Cortisol II assay. Investigators will conduct a study looking at healthy subjects to establish the expected range of peak cosyntropin-stimulated cortisol levels with two different cosyntropin administration modalities. The goal of this study is to compare intravenous (IV) and intramuscular (IM) administration, and to generate a normal range of post-cosyntropin serum cortisol measure with the new assay. The two aims of the study are: (1) Compare the cortisol values at baseline, 30 minutes and 60 minutes after IV and IM cosyntropin stimulation testing in the same subjects. (2) Generate assay-specific normal ACTH stimulation test results

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

• peak serum cortisol

  We will obtain peak serum cortisol level in nmol/L form each participant and determine the average

  60 minutes

Study Arms (1)

Intravenous and intramuscular administration

EXPERIMENTAL

Subjects will receive intravenous and intramuscular ACTH on different days

Drug: Cosyntropin

Interventions

Cosyntropin DRUG

intramuscular and intravenous administration

Intravenous and intramuscular administration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy volunteers

You may not qualify if:

• \- Know history of pituitary or adrenal disease. Current or recent use of glucocorticoids, and use of oral estrogen, pregnancy

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Cosyntropin

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: July 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share