Condition category
Urological and Genital Diseases
Date applied
27/03/2017
Date assigned
04/04/2017
Last edited
08/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

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
+44 1924 542297
martine.harris@midyorks.nhs.uk

Type

Scientific

Additional contact

Dr Bev Snaith

ORCID ID

http://orcid.org/0000-0002-6296-0889

Contact details

Mid Yorkshire Hospitals NHS Trust
Wakefield
WF1 4DG
United Kingdom
+44 1924 542034.
bev.snaith@midyorks.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33308

Study information

Scientific title

Streamlining cross-sectional imaging pathways (SCIPs): A feasibility and economic modelling study of point of care creatinine testing in radiology

Acronym

SCIPs

Study hypothesis

The 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

Sheffield Research Ethics Committee, 09/01/2017, ref: 16/YH/0520

Study design

Non-randomised; Both; Design type: Screening, Diagnosis, Device, Cohort study

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 below to request a patient information sheet

Condition

Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure

Intervention

The 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 type

Device

Phase

Drug names

Primary outcome measures

Renal function concordance measured as the difference between the serum creatinine value from PoCT and laboratory analysis at initial visit.

Secondary outcome measures

1. 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 trial start date

01/10/2016

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients attending for contrast-enhanced CT scan
2. Age over 18
3. Non-pregnant patients
4. Able to consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 300; UK Sample Size: 300

Participant exclusion criteria

1. 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

Recruitment start date

15/02/2017

Recruitment end date

30/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pinderfields Hospital
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Trial participating centre

Dewsbury District Hospital
Halifax Road
Dewsbury
WF13 4HS
United Kingdom

Sponsor information

Organisation

Mid Yorkshire Hospitals NHS Trust

Sponsor details

Rowan House
Aberford Road
Wakefield
WF1 4EE
United Kingdom
+44 1924 543175
MY.research@midyorks.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NHS England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication in a high-impact peer reviewed journal by end 2017
2. Presentation at UK Radiological Congress June 2017

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.