Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon

Adrenal Insufficiency Clinical Trial

Official title:

Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074123
• Other study ID #: 0003-17BNZ
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2019
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Israel	Mira Koch	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood cortisol	Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.	one day
Secondary	Salivary free cortisol	Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.	one day