Back to resultsCortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Primary Purpose
Adrenal Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
low-dose cosyntropin stimulation test
Sponsored by
About this trial
This is an interventional diagnostic trial for Adrenal Insufficiency focused on measuring cosyntropin stimulation test, low-dose
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
Clinical suspicion of hypoadrenalism Medical condition or treatment that might alter blood cortisol levels Pregnancy
Sites / Locations
- Mira Koch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
healthy subjects
Arm Description
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.
Outcomes
Primary Outcome Measures
Blood cortisol
Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Secondary Outcome Measures
Salivary free cortisol
Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Full Information
NCT ID
NCT03074123
First Posted
March 3, 2017
Last Updated
January 17, 2019
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03074123
Brief Title
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Official Title
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency
Keywords
cosyntropin stimulation test, low-dose
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
low-dose cosyntropin stimulation test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood cortisol
Description
Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Salivary free cortisol
Description
Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
Clinical suspicion of hypoadrenalism Medical condition or treatment that might alter blood cortisol levels Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Saiegh
Organizational Affiliation
Bni-Zion medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mira Koch
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
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