Status:
UNKNOWN
Optimising Steroid Replacement in Patients With Adrenal Insufficiency
Lead Sponsor:
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Conditions:
Adrenal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Adrenal insufficiency is a condition where the adrenal glands do not produce an adequate amount of steroid hormones. The aetiology of adrenal insufficiency can be primary or secondary. Patients will a...
Detailed Description
This is a prospective, cross-over study. This study cannot be blinded or placebo controlled due to the risk of adrenal crisis in the study population with primary and secondary adrenal insufficiency. ...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18years of age with Primary Adrenal Insufficiency (Addison's disease) confirmed on biochemical testing.
- Male or female patients ≥ 18years of age with ACTH deficiency defined by a stimulated peak cortisol in response to insulin-induced hypoglycaemia or short synacthen testing \<400 nmol/l, with known organic pituitary disease, and no adjustment in hormone replacement for at least 3 months prior to study entry.
- Signed informed consent to participate in the study
Exclusion
- Age \< 18 years
- Patients with acute medical or surgical illness
- Patients with advanced cardiac/pulmonary disease
- Patients with a terminal illness
- Patients on glucocorticoids for purposes other than ACTH deficiency
- Patients on agents that interfere with corticosteroid metabolism
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03282487
Start Date
September 5 2017
End Date
December 1 2019
Last Update
September 14 2017
Active Locations (1)
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1
Adelaide and Meath Hospital incorporating the National Childrens Hospital
Dublin, Ireland