A study to test a new way of more accurately measuring kidney function using fingerprick blood samples
| ISRCTN | ISRCTN14717076 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14717076 |
| IRAS number | 304466 |
| Secondary identifying numbers | S21KID09-S, IRAS 304466, CPMS 51877 |
- Submission date
- 27/07/2022
- Registration date
- 28/07/2022
- Last edited
- 04/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Blood tests used in kidney clinics estimate rather than measure kidney function. This means that they may not always be accurate. Here is also evidence that this inaccuracy affects some people more than others and may create health inequality. Clinical gold standard ways of actually measuring kidney function are time-consuming, expensive and have only limited availability. There is another gold standard test which involves injecting a dye and taking three or four blood tests over 5-6 hours to see how quickly the kidneys are removing this dye. This can be done in a routine way by injecting the dye when people come to clinic appointments and giving them a small kit that will allow them to take fingerprick blood samples at home later that day and post them back.
Who can participate?
Adult patients with chronic kidney disease attending renal outpatient appointments
What does the study involve?
Participants will be given a small injection of a dye when they come to the clinic and then have an extra teaspoon of blood with their usual clinic bloods and be shown how to use the fingerprick test kit. They will do the first fingerprick test in the clinic. They will take the kit home and do more tests 3, 4, and 5 hours later. Finally, they complete a feedback survey and everything is then posted back using a pack provided.
What are the possible benefits and risks of participating?
There is a small risk of allergic reaction as the dye contains iodine.
Where is the study run from?
Salford Royal Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2021 to August 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Darren Green, darren.green@nca.nhs.uk
Contact information
Principal Investigator
Dept Renal Medicine
Hope Building
Stott Lane
Salford
M6 8HD
United Kingdom
 ORCID ID |
0000-0002-9370-8176 |
|---|---|
| Phone | +44 (0)161 789 7373 |
| darren.green@nca.nhs.uk |
Study information
| Study design | Single-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Improving the accuracy of chronic kidney disease monitoring using postal finger prick iohexol measured glomerular filtration rate |
| Study objectives | The primary aim of the study is to show that iohexol measured glomerular filtration rate (mGFR) can be undertaken with a high level of accuracy by healthcare professionals and patients together using microstamping test kits at home after an injection of iohexol at an outpatient appointment. |
| Ethics approval(s) | Approved 01/03/2022, West of Scotland REC 4 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 22/WS/0016 |
| Health condition(s) or problem(s) studied | Patients with chronic kidney disease (CKD) where creatinine-based eGFR calculation may give spurious results |
| Intervention | Patients will be recruited from the renal outpatient department. Patients will receive a 5 ml bolus of Omnipaque followed by paired venous and fingerprick bloods 5 minutes post injection (time zero). Outpatients will have their appointment as usual and then go home with a home blood testing kit. Further fingerpick bloods will be taken by the patient at time points 3, 4 and 5 hours post-injection. The samples will be posted to the lab by the patient using an envelope provided in the kit. This can be done at any point in the 5 days after sample collection. An optional feedback survey will also be in the pack for completion and return. This is then the end of the study involvement. |
| Intervention type | Other |
| Primary outcome measure | Bland Altman comparison of fingerprick versus “gold standard” venous iohexol levels at time 0 using bias and P30 measurements |
| Secondary outcome measures | Percentage of participants in whom mGFR results differ from clinically used eGFR results to the extent that treatment is likely to have differed (e.g. drug dosing) had mGFR been used for clinical decision making at the time of study visit |
| Overall study start date | 21/12/2021 |
| Completion date | 01/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Adult patients with CKD |
| Key exclusion criteria | 1. Iodine intolerance 2. Unable to provide consent 3. Unable to perform fingerprick blood testing |
| Date of first enrolment | 02/08/2022 |
| Date of final enrolment | 31/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Eccles
Salford
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
1st Floor, Summerfield House
544 Eccles New Road
Salford
M5 5AP
England
United Kingdom
| Phone | +44 (0)1612067050 |
|---|---|
| NCA.Research@srft.nhs.uk |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | An anonymised dataset will be produced and supplied as a supplement at the time of publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/08/2022: Internal review.
28/07/2022: Trial's existence confirmed by the HRA.
