NCT03074123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

March 3, 2017

Last Update Submit

January 17, 2019

Conditions

Adrenal Insufficiency

Keywords

cosyntropin stimulation testlow-dose

Outcome Measures

Primary Outcomes (1)

  • Blood cortisol

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

    one day

Secondary Outcomes (1)

  • Salivary free cortisol

    one day

Study Arms (1)

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.

Diagnostic Test: low-dose cosyntropin stimulation test

Interventions

low-dose cosyntropin stimulation testDIAGNOSTIC_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.

healthy subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mira Koch

Haifa, Israel

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Leonard Saiegh

    Bni-Zion medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 8, 2017

Study Start

April 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)