Evaluation of High Dose Prednisolone Pharmacokinetics (EHD-Pred PK)
Research type
Research Study
Full title
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting (EHD-Pred PK)
IRAS ID
294260
Contact name
Karim Meeran
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
High doses of prednisolone, a type of synthetic steroid therapy, are used in a number of medical conditions such as asthma, allergy, inflammatory and auto-immune conditions. Its actions, however, are accompanied by several adverse side effects – including heart disease, diabetes and osteoporosis. These are more frequent following high doses and long-term treatment. The aim is therefore to use the lowest most effective dose or highest dose for the shortest duration required.
We often use standardised doses for a number of conditions, and therefore risk patients developing these adverse effects. It has been noticed, however that the way we metabolise prednisolone after being on high doses and for longer periods of time may change. This may mean the standardised doses which are so often used, become less effective if patients are receiving steroids for prolonged periods of time.
We therefore hope to develop further evidence to allow us to tailor the dose and weaning regimens used, thereby avoiding the deleterious side effects. We hope to be able to do this by measuring serum prednisolone levels in patients receiving high doses for different time periods.
It will involve patients (identified from electronic ward/clinic lists, or in clinic by the direct clinical team and with consent) who are receiving high dose steroids for any medical condition, to see whether there are changes in the blood levels of prednisolone over time. There will be two visits involving measurements (such as height, weight, waist and hip circumference, blood pressure and heart rate), blood samples and a 24h urine collection.
The study is being funded by Imperial College London and an internal funding source (Private patient fund).REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0143
Date of REC Opinion
5 Jul 2021
REC opinion
Further Information Favourable Opinion