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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

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE March 8, 2017
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2017)
Blood cortisol [ Time Frame: one day ]
Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • Blood cortisol [ Time Frame: one year ]
    Serum cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
  • Salivary free cortisol [ Time Frame: one year ]
    Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Change History Complete list of historical versions of study NCT03074123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2017)
Salivary free cortisol [ Time Frame: one day ]
Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation through short tube.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
Official Title  ICMJE Cortisol Response to Low Dose Cosyntropin Stimulation Test in the Late Afternoon
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Adrenal Insufficiency
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Diagnostic Test: low-dose cosyntropin stimulation test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03074123
Other Study ID Numbers  ICMJE 0003-17BNZ
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party leonard.saiegh, Bnai Zion Medical Center
Study Sponsor  ICMJE Bnai Zion Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonard Saiegh Bni-Zion medical center
PRS Account Bnai Zion Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP