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

Not Applicable

Completed

• Conditions: Adrenal Insufficiency
• Interventions: Diagnostic Test: low-dose cosyntropin stimulation test

• Registration Number: NCT03074123
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-08
• Study Start: 2017-04-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

healthy volunteers

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy subjects	low-dose cosyntropin stimulation test	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.

Primary Outcome Measures

Name	Time	Method
Blood cortisol	one day	Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.

Secondary Outcome Measures

Name	Time	Method
Salivary free cortisol	one day	Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.

Trial Locations

Locations (1)

Mira Koch; 🇮🇱 Haifa, Israel