Streamlining cross-sectional imaging pathways (SCIPs)

ISRCTN ISRCTN62796844
DOI https://doi.org/10.1186/ISRCTN62796844
Secondary identifying numbers 33308
Submission date
27/03/2017
Registration date
04/04/2017
Last edited
08/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Computerised Tomography (CT) is a radiology test which takes cross-sectional images of the body using radiation (x-rays) and is vital for diagnosing (or excluding) cancer. To improve the visibility of internal organs and structures on these scans, an x-ray dye is injected into the bloodstream. This x-ray dye is commonly referred to as contrast media. In patients with reduced kidney function, the use of contrast media can cause complications. Guidelines published by the Royal College of Radiologists (RCR) recommend a blood test to measure kidney function should be available from the preceding three months for all patients referred for CT scans including contrast. There are a variety of pathways to ensure that a blood test is performed before the scan, some of which may delay imaging. The blood test allows patients with reduced kidney function to be identified, as there is a risk of Contrast Induced Acute Kidney Injury (CI-AKI). As the waiting time for imaging tests are reduced, it is important to identify how services can be streamlined. A national survey undertaken by the research team has demonstrated diversity in the current service delivery pathways for obtaining kidney function prior to cross-sectional imaging across the UK. A small number of sites offer point of care testing (PoCT) for kidney function in patients who have not had a recent blood test. However, the potential impact of their application is unknown. The aim of this study is to evaluate whether PoCT devices for determining kidney function levels can be used to streamline the patient pathway.

Who can participate?
Adult patients who are attending an appointment for a contrast-enhanced CT scan

What does the study involve?
When participants attend for their CT appointment they have an additional blood sample taken. The sample is then analysed using the PoCT device and is also sent to the lab so it can undergo standard testing to assess participant’s kidney function. Participants are asked to return for another study visit 2-3 days later for a follow up blood test which is analysed the same way.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.

Where is the study run from?
1. Pinderfields Hospital (UK)
2. Dewsbury District Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2016 to May 2017

Who is funding the study?
NHS England (UK)

Who is the main contact?
1. Miss Martine Harris (public)
martine.harris@midyorks.nhs.uk
2. Dr Bev Snaith (scientific)
bev.snaith@midyorks.nhs.uk

Contact information

Miss Martine Harris
Public

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

ORCiD logoORCID ID 0000-0003-1924-3718
Phone +44 1924 542297
Email martine.harris@midyorks.nhs.uk
Dr Bev Snaith
Scientific

Mid Yorkshire Hospitals NHS Trust
Wakefield
WF1 4DG
United Kingdom

ORCiD logoORCID ID 0000-0002-6296-0889
Phone +44 1924 542034.
Email bev.snaith@midyorks.nhs.uk

Study information

Study designNon-randomised; Both; Design type: Screening, Diagnosis, Device, Cohort study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleStreamlining cross-sectional imaging pathways (SCIPs): A feasibility and economic modelling study of point of care creatinine testing in radiology
Study acronymSCIPs
Study objectivesThe aim of this study is to assess the feasibility of using a point of care blood test (PoCT) performed in radiology rather than the standard laboratory test.
Ethics approval(s)Sheffield Research Ethics Committee, 09/01/2017, ref: 16/YH/0520
Health condition(s) or problem(s) studiedSpecialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure
InterventionThe intervention is a PoC creatinine test and a standard laboratory renal function blood test performed at the initial visit (CT scan appointment), this will take 5 minutes. This whole blood sample is processed on the point of care device according to manufacturer’s recommendations. The standard care blood sample is analysed in the laboratory on a Roche Cobas 8000 series, using an enzymatic creatinine method, according to standard operating procedures.

Participants will be asked to return at 2-3 days post-contrast administration for a follow up blood test to be analysed on both the PoC device and in the laboratory.
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureRenal function concordance measured as the difference between the serum creatinine value from PoCT and laboratory analysis at initial visit.
Secondary outcome measures1. Recruitment rate recorded as the number of eligible participants who consented to participate in the study at initial visit
2. Attrition rate recorded as the number of participants that return for follow up blood test at 2-3 days post-contrast administration
3. Failure rate recorded as the number of test analyses which do not produce a result from PoC and laboratory tests at initial and follow up visits
4. Screening questionnaire effectiveness measured as the number of patients with no risk factors who have a reduced renal function identified (eGFR <40) at initial visit
5. Renal function recorded as the concordance between serum creatinine and eGFR from the pre-scan result obtained within 3 months of scan and the renal function at initial visit
6. Rate of contrast-induced acute kidney injury (CI-AKI) recorded as the number of participants who have a ≥25% rise in serum creatinine on follow up blood test 2-3 days post-contrast administration
Overall study start date01/10/2016
Completion date31/05/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 300; UK Sample Size: 300
Key inclusion criteria1. Patients attending for contrast-enhanced CT scan
2. Age over 18
3. Non-pregnant patients
4. Able to consent
Key exclusion criteria1. Patients undergoing a non-contrast CT scan or other radiology test
2. Patients under 18 years
3. Pregnant patients
4. Those unable to provide written consent
Date of first enrolment15/02/2017
Date of final enrolment30/04/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Dewsbury District Hospital
Halifax Road
Dewsbury
WF13 4HS
United Kingdom

Sponsor information

Mid Yorkshire Hospitals NHS Trust
Hospital/treatment centre

Rowan House
Aberford Road
Wakefield
WF1 4EE
England
United Kingdom

Phone +44 1924 543175
Email MY.research@midyorks.nhs.uk
ROR logo "ROR" https://ror.org/05g23q746

Funders

Funder type

Government

NHS England

No information available

Results and Publications

Intention to publish date01/10/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan1. Planned publication in a high-impact peer reviewed journal
2. Presentation at UK Radiological Congress June 2017
IPD sharing planThe current 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 01/03/2019 Yes No
HRA research summary 26/07/2023 No No

Editorial Notes

08/04/2019: Publication reference added.
07/08/2018: The intention to publish date was changed from 31/12/2017 to 01/10/2018.
08/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.