Improving Patient Assessment After Acute Kidney Injury (AKI)

NCT07569588 | Recruiting

• 1 other identifier: 25019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Acute Kidney Injury

Keywords

acute kidney injury; chronic kidney disease; patient reported outcome measures

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (10)

• 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

Other Outcomes (1)

• Safety Outcomes

  From enrolment until the end of study visits (from 3 to 12 months)

Study Arms (3)

Observational study

Patients 3 months after hospitalised acute kidney injury

Diagnostic Test: Iohexol renal clearance measurement; Diagnostic Test: Cystatin C; Diagnostic Test: Creatinine; Diagnostic Test: Metagenome analysis; Diagnostic Test: Bioimpedance analysis; Other: Patient reported outcome measures; Other: Measurement of physical performance

Qualitative study

Patients 3 months after hospitalised acute kidney injury

Other: Semi structured interview

Participatory workshops

Individuals with personal or professional experience of acute kidney injury

Other: Participatory workshop

Interventions

Cystatin C DIAGNOSTIC_TEST

Estimated GFR using serum cystatin C

Observational study

Creatinine DIAGNOSTIC_TEST

eGFR from serum creatinine level

Observational study

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.

Qualitative study

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.

Participatory workshops

Metagenome analysis DIAGNOSTIC_TEST

Analysis of the metagenome using faecal samples of participants after acute kidney injury

Observational study

Bioimpedance analysis DIAGNOSTIC_TEST

Estimation of body composition

Observational study

Patient reported outcome measures OTHER

EQ-5D-5L, KSQ, WHO-DAS 2.0, K10

Observational study

Measurement of physical performance OTHER

Hand grip, Short physical performance battery

Observational study

Iohexol renal clearance measurement DIAGNOSTIC_TEST

Gold standard measurement of glomerular filtration rate.

Observational study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• days after peak creatinine Qualitative interview workstream
• Age 18-85 years
• AKI during hospital admission
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, urine, faeces

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Nicholas Selby

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry Horne Dr, BMBCh

CONTACT

+44 01332 788262; kerry.horne@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: May 6, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2025-12

Locations

GB (1)