Improving Patient Assessment After Acute Kidney Injury (AKI)

Overview

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 test Iohexol renal clearance measurement
  Gold standard measurement of glomerular filtration rate.
• Diagnostic test Cystatin C
  Estimated GFR using serum cystatin C
• Diagnostic test Creatinine
  eGFR from serum creatinine level
• Other Semi structured interview
  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.
• Other Participatory 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 test Metagenome analysis
  Analysis of the metagenome using faecal samples of participants after acute kidney injury
• Diagnostic test Bioimpedance analysis
  Estimation of body composition
• Other Patient reported outcome measures
  EQ-5D-5L, KSQ, WHO-DAS 2.0, K10
• Other Measurement of physical performance
  Hand grip, Short physical performance battery

Primary outcome measures

• The proportion of eligible patients who agree to participate [Time frame: 3 months]
• The proportion of participants who have all three measurements (eGFR-cystatin, eGFR-creatinine and measured GFR) [Time frame: 3 months]
• Standard deviation of the difference between measured GFR and eGFR-creatinine and eGFR-cystatin [Time frame: 3 months]
• The proportion of patients with eGFR <60ml/min/1.73m2 from eGFR-cystatin compared with eGFR creatinine [Time frame: 3 months]
• Gut microbiome composition [Time frame: 3 months]
• Codes and themes related to patient experience after AKI, identified from systematic qualitative analysis of interview transcripts [Time frame: 3 - 12 months]
• Production of a document of recommended next steps through MDT development during participatory workshops [Time frame: At completion of third workshop 3 years after enrolment]

Secondary outcome measures (10)

• The mean difference between eGFR-cystatin and eGFR-creatinine [Time frame: 3 months]
• The mean difference between iohexol measured GFR and each estimated GFR method (creatinine and cystatin) [Time frame: 3 months]
• Correlation between eGFR creatinine and eGFR cystatin [Time frame: 3 months]
• Correlation between iohexol measured GFR and each estimated GFR method (creatinine and cystatin) [Time frame: 3 months]
• Bias between iohexol measured GFR and each estimated GFR method (creatinine and cystatin) [Time frame: 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) [Time frame: 3 months]
• Correlation of muscle mass with the percentage difference between eGFR-cystatin and eGFR-creatinine [Time frame: 3 months]
• Correlation of physical function with the percentage difference between eGFR-cystatin and eGFR-creatinine [Time frame: 3 months]
• Correlation of patient reported outcomes with the percentage difference between eGFR-cystatin and eGFR-creatinine [Time frame: 3 months]
• Barriers to implementation of recommendations as identified through MDT discussion at participatory workshops [Time frame: At completion of third workshop 3 years after enrolment]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• University Hospitals of Derby and Burton NHS Foundation Trust — Derby

Identifiers

NCT: NCT07569588 · 25019

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗