ECE2023 Poster Presentations Adrenal and Cardiovascular Endocrinology (72 abstracts)
RESCUE: Effect of supplemental hydrocortisone during stress in glucocorticoid-induced adrenal insufficiency; A study protocol for a multicentre, randomised, double blinded, placebo-controlled clinical trial
Stina Willemoes Borresen 1 , Simon Bøggild Hansen 2,3 , Hajir Al-Jorani 4,5 , Lise Sofie Bislev 2 , Jakob Bue Bjørner 6,7,8 , Victor Brun Boesen 1 , Louise Lehmann Christensen 4,5 , Anja Fenger Dreyer 4,5 , Dorte Glintborg 4 , Richard Christian Jensen 4 , Nanna Thurmann Jørgensen 1,9 , Marianne Klose 1 , Marie Louise Lund 1,9 , Jelena Stankovic 2,3 , Randi Tei 2 , Torquil Watt 1,9 , Jens Otto Lunde Jørgensen 2,3 , Marianne Skovsager Andersen 4,5 & Ulla Feldt-Rasmussen 1,9
1Copenhagen University Hospital, Rigshospitalet, Department of Medical Endocrinology and Metabolism, Copenhagen, Denmark; 2Aarhus University Hospital, Department of Endocrinology and Internal Medicine, Aarhus, Denmark; 3Aarhus University, Department of Clinical Medicine, Aarhus, Denmark; 4Odense University Hospital, Department of Endocrinology and Metabolism, Odense, Denmark; 5University of Southern Denmark, Department of Clinical Research, Odense, Denmark; 6University of Copenhagen, Department of Public Health, Copenhagen, Denmark; 7QualityMetric incorporated, LLC, Johnston, RI, United States; 8National Research Centre for the Working Environment, Copenhagen, Denmark; 9University of Copenhagen, Department of Clinical Medicine, Faculty of Health and Clinical Sciences, Copenhagen, Denmark
Background: Long-term, low-dose prednisolone treatment (≤5mg/day) is associated with adrenal insufficiency in >33% of patients. Nevertheless, the clinical consequences of glucocorticoid-induced adrenal insufficiency in patients receiving ongoing low-dose glucocorticoid treatment are unknown. Current clinical guidelines do not recommend routine evaluation of adrenal function during low-dose glucocorticoid treatment, and patients are not routinely instructed to increase glucocorticoid intake during stress.
Aim: To determine the effect of supplemental hydrocortisone during mild to moderate stress on health-related quality of life (HRQoL) in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) receiving ongoing low-dose (≤5mg/day) prednisolone treatment.
Methods: A multicentre, randomised, double blinded, placebo-controlled, clinical trial (EudraCT number 2021-002528-18). The study includes patients with PMR/GCA receiving ongoing prednisolone treatment ≤5mg/day. Eligible patients undergo an ACTH test, and 250 patients with a stimulated cortisol <420nmol/l (biochemical adrenal insufficiency) are randomised 1:1 to either supplemental doses of placebo or hydrocortisone during stress. Patients continue prednisolone treatment and tapering hereof according to current clinical guidelines and add on supplemental study drug in situations of stress according to the study protocol. In situations of severe stress (risk of developing adrenal crisis), patients receive open label hydrocortisone treatment according to routine clinical care. Seventy-five patients with stimulated cortisol ≥420 nmol/l constitute a control group. The participants undergo screening (ACTH test) and baseline examinations, 6 month’s HRQoL reporting and follow-up ACTH tests and examinations at 3 and 6 months.
Outcomes: HRQoL is evaluated using a specially developed study smartphone application (app) and with generic and disease-specific questionnaires (SF-36v2, Addiqol-30, CushingQol and Single item Sleep Quality Scale). The app prompts daily ‘end-of-day’ assessments and obtains information about intercurrent illness, injury, or stress, and symptoms attributable to adrenal insufficiency. The primary outcome is ecological momentary assessments of the Multidimensional Fatigue Inventory, General Fatigue scale, in situations of stress. This scale is prompted to the patient five times daily at semi-randomised time points, for three days, if triggered by stress, or at fixed timepoints monthly (unstressed conditions). Secondary outcomes include the other HRQoL measures (key secondary outcomes), incidence and grade of adrenal crises, PMR/GCA treatment characteristics, measures of exogenous Cushing’s syndrome (body composition, muscle strength, bone quality, metabolic and cardiovascular risk) and biomarkers for adrenal insufficiency, glucocorticoid sensitivity and action.
Funding: Achieved from the Novo Nordisk Foundation as part of a collaborative grant entitled ‘DOUBLE EDGE – Characterization and mitigation of adverse effects of glucocorticoid treatment’ (NNF20OC0063280).
Status: Recruiting.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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