Condition category
Urological and Genital Diseases
Date applied
14/08/2017
Date assigned
21/08/2017
Last edited
20/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Martine Harris

ORCID ID

http://orcid.org/0000-0003-1924-3718

Contact details

Rowan House
Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31955

Study information

Scientific title

Method comparison and bias estimation of point of care creatinine tests against standard of care laboratory testing by enzymatic method

Acronym

BEPoCC

Study hypothesis

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

South East Scotland REC2, 13/06/2016, IRAS: 202240, REC ref: 16/SS/0077

Study design

Non-randomised; interventional and observational. Design type: Validation of outcome measures

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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 names

Primary outcome measure

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

01/02/2016

Overall trial end date

29/11/2016

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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

07/09/2016

Recruitment end date

26/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pinderfields Hospital
Wakefield
WF1 4DG
United Kingdom

Sponsor information

Organisation

Mid Yorkshire Hospitals NHS Trust

Sponsor details

Rowan House
Aberford Road
Wakefield
WF1 4EE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Yorkshire & Humber Academic Health Science Network

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/11/2017

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29672267

Publication citations

Additional files

Editorial Notes

20/07/2018: Publication reference added. 23/08/2017: Internal edits.