Status:
NOT_YET_RECRUITING
Post-corticosteroid Insufficiency: Search for a Threshold Value for Cortisol at 8 Hours, Prospective Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Glucocorticoid-induced Adrenal Insufficiency
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
Post-corticosteroid insufficiency is found in 40-60% of patients within 10 weeks following the cessation of prolonged corticosteroid therapy and in 20% of patients still after 1 year. Screening in ped...
Detailed Description
Synthetic glucocorticoids are widely used in medicine for their anti-inflammatory and immunomodulating effects. There are 1-2% of the population treated with synthetic glucocorticoids; among them, aro...
Eligibility Criteria
Inclusion
- Age 6 months - 17 years
- Treatment with glucocorticoids for at least 3 weeks at doses ≥ 3 mg/m2 prednisone equivalent OR Treatment with inhaled corticosteroids (ICS) for \> 12 months OR high-dose ICS \> 6 months OR ICS \> 6 months at any dose in combination with other topical corticosteroids.
- Withdrawal of corticosteroid therapy EXCEPT ICS and topical corticosteroids (tapering off) and/or replacement therapy (\< 3 mg/m2/day, eq. Prednisone) for at least 4 weeks.
- Prescription for Synacthen test including 4 blood samples (T0, T20, T30, T60)
- No objection from a legal representative or the child taken in by the doctor
Exclusion
- Use of glucocorticoids INCLUDING TOPICALS AND ICS in the 12 hours preceding the test
- Opposition of the child or legal guardians
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06208098
Start Date
March 1 2024
End Date
April 1 2026
Last Update
January 17 2024
Active Locations (1)
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1
Robert Debre Hospital
Paris, France, 75019