RAPID
Research type
Research Study
Full title
Renal function Assessment with Point of care creatinine testing In Diverse populations (RAPID)
IRAS ID
263206
Contact name
Kate Bramham
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This is a multi-centre cross-sectional and prospective longitudinal cohort study. Primary objectives include assessment of Point of Care Creatinine (POC-Cr) accuracy and precision in order to define thresholds for screening which identify individuals with Chronic Kidney Disease (CKD) (Study A) and exploration of variability and patient acceptability of self-monitoring of POC-Cr including Ease or Simplicity of Use (Study B).
375 participants (including at least 125 of African/African-Caribbean ancestry and 125 Asian background) having venous serum creatinine and 99mTc-DTPA nuclear medicine testing will be recruited to a cross sectional study (Study A).
40 patients with CKD or at risk of kidney disease will be recruited to a one week longitudinal study (Study B).
Study A: POC-Cr will be assessed on a drop of capillary whole blood by the research team and venous serum creatinine for routine care (Isotope Dilution Mass Spectrometry (IDMS) Traceable Enzymatic assay) and 99mTc-DTPA glomerular filtration rate testing will be extracted from hospital laboratory databases.
Study B: Participants will be trained to use the StatSensor® by the research team and time taken recorded. Participants will be taught how to perform quality controls, finger prick lancing and sample analysis. All sample results will be digitally recorded by the device and downloaded after the device is returned. Participants will be asked to self-monitor four times per day (first thing in morning, midday, before evening meal/early evening, before bed) and each test recorded in a paper diary or electronically as desired. Details reported will include time of test, test success, device and non-device failures (test results, missed testing and reasons for missed test (e.g. forgot, did not want to test) and adverse events (e.g. pain, infection, pre-syncopal or syncopal episode).
REC name
London - Bromley Research Ethics Committee
REC reference
20/LO/0620
Date of REC Opinion
17 Jul 2020
REC opinion
Further Information Favourable Opinion