Method comparison and bias estimation of point of care creatinine test
| ISRCTN | ISRCTN18805212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18805212 |
| Protocol serial number | 31955 |
| Sponsor | Mid Yorkshire Hospitals NHS Trust |
| Funder | Yorkshire & Humber Academic Health Science Network |
- Submission date
- 14/08/2017
- Registration date
- 21/08/2017
- Last edited
- 20/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Rowan House
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
 ORCID ID |
0000-0003-1924-3718 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; interventional and observational. Design type: Validation of outcome measures |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Method comparison and bias estimation of point of care creatinine tests against standard of care laboratory testing by enzymatic method |
| Study acronym | BEPoCC |
| Study objectives | 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. |
| Ethics approval(s) | South East Scotland REC2, 13/06/2016, IRAS: 202240, REC ref: 16/SS/0077 |
| Health condition(s) or problem(s) studied | Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Blood/ Other diseases of blood and blood-forming organs |
| Intervention | 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. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Failure rates, recorded as the number of test analyses which do not produce a result from PoCT and laboratory tests at day 1 |
| Completion date | 29/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key exclusion criteria | 1. Under 18 years of age 2. Pregnant patients 3. Those unable to provide consent |
| Date of first enrolment | 07/09/2016 |
| Date of final enrolment | 26/10/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
WF1 4DG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/07/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/07/2018: Publication reference added.
23/08/2017: Internal edits.
