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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
Sponsor:
Information provided by (Responsible Party):
leonard.saiegh, Bnai Zion Medical Center

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.

Condition or disease Intervention/treatment Phase
Adrenal Insufficiency Diagnostic Test: low-dose cosyntropin stimulation test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Blood cortisol [ Time Frame: one day ]
    Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.


Secondary Outcome Measures :
  1. Salivary free cortisol [ Time Frame: one day ]
    Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

Clinical suspicion of hypoadrenalism Medical condition or treatment that might alter blood cortisol levels Pregnancy


Information from the National Library of Medicine

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


Locations
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Israel
Mira Koch
Haifa, Israel
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
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Principal Investigator: Leonard Saiegh Bni-Zion medical center

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Responsible Party: leonard.saiegh, MD, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT03074123     History of Changes
Other Study ID Numbers: 0003-17BNZ
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by leonard.saiegh, Bnai Zion Medical Center:
cosyntropin stimulation test
low-dose
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cosyntropin
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs