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Clinical Trials/NCT03074123
NCT03074123CompletedNot Applicable

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

Bnai Zion Medical Center1 site in 1 country20 target enrollmentStarted: April 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Blood cortisol

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •healthy volunteers

Exclusion Criteria

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

Arms & Interventions

healthy subjects

Experimental

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: low-dose cosyntropin stimulation test (Diagnostic Test)

Outcomes

Primary Outcomes

Blood cortisol

Time Frame: one day

Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.

Secondary Outcomes

  • Salivary free cortisol(one day)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

leonard.saiegh

MD

Bnai Zion Medical Center

Study Sites (1)

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