Plain English Summary
Background and study aims
When patients need an x-ray they first need to have a blood test to check that their kidney function (estimated Glomerular Filtration rate [eGFR]) is normal. The blood test identifies patients with reduced kidney function as they are at risk of kidney injury as a result of the injection of x-ray dye. The aim of this study is to test whether a point of care test (POCT) is as accurate as a standard test to see whether it can be used to improve patient care.
Who can participate?
Patients aged over 18 who are already having a blood test (U&Es)
What does the study involve?
Participants undergo a standard blood test and extra blood tests using POCT devices using both venous (vein) and finger prick blood. The results of the blood tests are compared.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in the study.
Where is the study run from?
Pinderfields Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2016 to November 2016
Who is funding the study?
Yorkshire & Humber Academic Health Science Network (UK)
Who is the main contact?
Miss Martine Harris
Miss Martine Harris
Method comparison and bias estimation of point of care creatinine tests against standard of care laboratory testing by enzymatic method
The aim of this study to test whether a point of care test (POCT) for bloods is as accurate as a standard pathology test to enable it to be considered for use in radiology to improve patient care pathways. This will enable the trialists to develop a trial to evaluate the impact of POCT on a Radiology service.
South East Scotland REC2, 13/06/2016, IRAS: 202240, REC ref: 16/SS/0077
Non-randomised; interventional and observational. Design type: Validation of outcome measures
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Blood/ Other diseases of blood and blood-forming organs
Additional blood tests are performed utilising POCT devices on outpatients routinely referred to phlebotomy for blood (U&E) testing as part of their standard pathway. Patients will be identified as attending for U&E’s in the phlebotomy department and those attending for other blood tests will be excluded. Patients identified will be recruited and consented for their agreement to have both a standard pathology blood test and a POCT (using both venous and capillary finger prick) blood. Accuracy using method comparison and bias estimation will be carried out on the patient samples in accordance with established laboratory standards.To ensure patients with a range of blood results are identified a modified Choyke screening questionnaire will be used to identify those with potentially reduced kidney function who would be the group most at risk in any future radiology based studies.
Primary outcome measures
Renal function concordance measured as the difference between Estimated Glomerular Filtration Rate (eGFR) measurements calculated from serum creatinine measurements recorded by the standard pathology test and each point of care device (not POCT vs POCT); Timepoint(s): Day 1 only
Secondary outcome measures
1. Failure rates, recorded as the number of test analyses which do not produce a result from PoCT and laboratory tests at day 1
2. Appropriateness of the modified Choyke screening questionnaire to identify patients with reduced renal function, measured as the number of patients with no risk factors who have a reduced renal function identified (eGFR<40) at day 1
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients who are already having a blood test for U&Es (other assays will be excluded from the results)
2. The inclusion of non-English speaking patients will be made on a case-by-case basis
3. Those participants who are able to provide consent but are unable to read or write will be offered the opportunity for a witness to sign the participant consent sheet on their behalf
4. Over 18 years of age
Target number of participants
Planned Sample Size: 300; UK Sample Size: 300
Participant exclusion criteria
1. Under 18 years of age
2. Pregnant patients
3. Those unable to provide consent
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Yorkshire & Humber Academic Health Science Network
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
An e-poster was presented at the European Congress of Radiology (ECR), March 2017. Planned publication in a high-impact peer reviewed journal. The intention is to publish by November 2017.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting