Method comparison and bias estimation of point of care creatinine test
Completed
- Conditions
- Specialty: Renal disorders, Primary sub-specialty: Renal disordersUKCRC code/ Disease: Blood/ Other diseases of blood and blood-forming organsUrological and Genital Diseases
- Registration Number
- ISRCTN18805212
- Lead Sponsor
- Mid Yorkshire Hospitals NHS Trust
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29672267
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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
Exclusion Criteria
1. Under 18 years of age
2. Pregnant patients
3. Those unable to provide consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Failure rates, recorded as the number of test analyses which do not produce a result from PoCT and laboratory tests at day 1<br>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