Acute Kidney Injury
Conditions
Keywords
acute kidney injury, chronic kidney disease, patient reported outcome measures
Brief summary
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: 1. Is creatinine or cystatin a more reliable assessment of kidney function after AKI? 2. What are the experiences of patients after AKI? 3. What interventions should be recommended to improve assessment and support of patients after AKI? Participants will be asked to do one or more of: * blood tests to measure kidney function in different ways * have measurement of their body composition * complete questionnaires about their symptoms * have an interview with a researcher about their experiences * discussion to develop an action plan based on findings
Interventions
DIAGNOSTIC_TESTIohexol renal clearance measurement
Gold standard measurement of glomerular filtration rate.
DIAGNOSTIC_TESTCystatin C
Estimated GFR using serum cystatin C
DIAGNOSTIC_TESTCreatinine
eGFR from serum creatinine level
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.
OTHERParticipatory workshop
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.
DIAGNOSTIC_TESTMetagenome analysis
Analysis of the metagenome using faecal samples of participants after acute kidney injury
DIAGNOSTIC_TESTBioimpedance analysis
Estimation of body composition
OTHERPatient reported outcome measures
EQ-5D-5L, KSQ, WHO-DAS 2.0, K10
OTHERMeasurement of physical performance
Hand grip, Short physical performance battery
Sponsors
University of Nottingham
University Hospitals of Derby and Burton NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Observational study workstream * Age 18-85 years * AKI stage 2 or 3 during hospital admission OR AKI stage 1 of at least 7 days duration during hospital admission * 60-90 days after peak creatinine Qualitative interview workstream * Age 18-85 years * AKI during hospital admission * 60-90 days after peak creatinine Participatory workshop workstream * Age 18-85 years * Relevant experience (as assessed by the investigator) which could include personal experience of an episode of hospitalised AKI as a patient of carer, experience of managing AKI or related problems in a professional capacity or knowledge of a particular community.
Exclusion criteria
Observational study workstream * Inability to give informed consent * No baseline creatinine available in previous 12 months * Pregnancy or breastfeeding * Current treatment with dialysis * Renal transplant * Pacemaker in situ * Previous amputation * Allergy to Omnipaque contrast agent (WP1 only) * Manifest thyrotoxicosis (WP1 only) * Ascites or significant (grade 3 to 4) peripheral oedema, defined as ≥6 mm pit, lasting for \>1 minute after 5-second compression over tibia or medial malleolus (WP1 only) Qualitative interview workstream * Inability to give informed consent * No baseline creatinine available in previous 12 months * Current treatment with dialysis * Renal transplant * Receiving palliative care Participatory workshop workstream * Inability to give informed consent * Inability to communicate in English (the qualitative workshops will be held in English)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months | Assessed through metagenomics |
| 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 | — |
Secondary
| Measure | 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 |
| 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 |
Countries
United Kingdom
Contacts
CONTACTKerry Horne Dr, BMBCh
PRINCIPAL_INVESTIGATORNicholas Selby
University of Nottingham
Outcome results
None listed