Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
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|ClinicalTrials.gov Identifier: NCT03074123|
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adrenal Insufficiency||Diagnostic Test: low-dose cosyntropin stimulation test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
Experimental: healthy subjects
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.
Diagnostic Test: low-dose cosyntropin stimulation test
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.
- Blood cortisol [ Time Frame: one day ]Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
- Salivary free cortisol [ Time Frame: one day ]Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074123
|Principal Investigator:||Leonard Saiegh||Bni-Zion medical center|