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| Name | Class |
|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | OTHER |
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The goal of this clinical trial is to improve patient care after acute kidney injury (AKI). It has three related parts. The main questions it aims to answer are:
Participants will be asked to do one or more of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational study | Patients 3 months after hospitalised acute kidney injury |
| |
| Qualitative study | Patients 3 months after hospitalised acute kidney injury |
| |
| Participatory workshops | Individuals with personal or professional experience of acute kidney injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iohexol renal clearance measurement | Diagnostic Test | Gold standard measurement of glomerular filtration rate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of eligible patients who agree to participate | 3 months | |
| The proportion of participants who have all three measurements (eGFR-cystatin, eGFR-creatinine and measured GFR) | 3 months | |
| Standard deviation of the difference between measured GFR and eGFR-creatinine and eGFR-cystatin | 3 months | |
| The proportion of patients with eGFR <60ml/min/1.73m2 from eGFR-cystatin compared with eGFR creatinine | 3 months | |
| Gut microbiome composition | Assessed through metagenomics | 3 months |
| Codes and themes related to patient experience after AKI, identified from systematic qualitative analysis of interview transcripts | 3 - 12 months | |
| Production of a document of recommended next steps through MDT development during participatory workshops | At completion of third workshop 3 years after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| The mean difference between eGFR-cystatin and eGFR-creatinine | 3 months | |
| The mean difference between iohexol measured GFR and each estimated GFR method (creatinine and cystatin) | 3 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes |
| From enrolment until the end of study visits (from 3 to 12 months) |
Inclusion Criteria:
Observational study workstream
Exclusion Criteria:
Observational study workstream
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Observational study workstream: secondary care nephrology clinics Qualitative interview workstream: secondary care nephrology clinics, hospitalised patients with AKI not followed up in nephrology clinic, participants of other aspects of the study.
Participatory workshop workstream: Organisational and professional organisations with interest in acute kidney injury, professional networks, public and patient involvement and engagement groups
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerry Horne Dr, BMBCh | Contact | +44 01332 788262 | kerry.horne@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas Selby | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | Recruiting | Derby | Derbyshire | DE22 3DT | United Kingdom |
IPD sharing will be available on request through the study team and individual applications will be considered.
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serum, plasma, urine, faeces
| Cystatin C | Diagnostic Test | Estimated GFR using serum cystatin C |
|
| Creatinine | Diagnostic Test | eGFR from serum creatinine level |
|
| Semi structured interview | Other | Semi structured interview to explore patient experiences. Purposive sampling will be used to explore a wide range of perspectives and transcripts will be analysed using thematic analysis to develop codes and themes. |
|
| Participatory workshop | Other | Group workshop using qualitative methods. Purposive sampling will be used to explore a wide range of perspectives and transcripts will be analysed using thematic analysis to develop codes and themes. These will be used to develop consensus recommendations. |
|
| Metagenome analysis | Diagnostic Test | Analysis of the metagenome using faecal samples of participants after acute kidney injury |
|
| Bioimpedance analysis | Diagnostic Test | Estimation of body composition |
|
| Patient reported outcome measures | Other | EQ-5D-5L, KSQ, WHO-DAS 2.0, K10 |
|
| Measurement of physical performance | Other | Hand grip, Short physical performance battery |
|
| Correlation between eGFR creatinine and eGFR cystatin |
| 3 months |
| Correlation between iohexol measured GFR and each estimated GFR method (creatinine and cystatin) | 3 months |
| Bias between iohexol measured GFR and each estimated GFR method (creatinine and cystatin) | 3 months |
| Accuracy of eGFR creatinine and eGFR cystatin compared with iohexol measured GFR as assessed by the percentage of estimated values within 30% of measured GFR (P30) | 3 months |
| Correlation of muscle mass with the percentage difference between eGFR-cystatin and eGFR-creatinine | 3 months |
| Correlation of physical function with the percentage difference between eGFR-cystatin and eGFR-creatinine | 3 months |
| Correlation of patient reported outcomes with the percentage difference between eGFR-cystatin and eGFR-creatinine | 3 months |
| Barriers to implementation of recommendations as identified through MDT discussion at participatory workshops | At completion of third workshop 3 years after enrolment |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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