Acute Kidney InjuryIMPACT-AKINCT07569588
Improving Patient Assessment After Acute Kidney Injury (AKI)
An observational study of Acute Kidney Injury, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Iohexol renal clearance measurement, Cystatin C and Creatinine
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2026to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT
Kerry Horne Dr, 01332788262, kerry.horne@nottingham.ac.uk
About this study
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:
- Is creatinine or cystatin a more reliable assessment of kidney function after AKI?
- What are the experiences of patients after AKI?
- 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
- Conditions
- Acute Kidney Injury
- Being tested
- Iohexol renal clearance measurement, Cystatin C, Creatinine, Semi structured interview, Participatory workshop
- Keywords
- acute kidney injury, chronic kidney disease, patient reported outcome measures
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iohexol renal clearance measurementDiagnostic test
Gold standard measurement of glomerular filtration rate.
Cystatin CDiagnostic test
Estimated GFR using serum cystatin C
CreatinineDiagnostic test
eGFR from serum creatinine level
Semi structured interviewOther
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 workshopOther
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 analysisDiagnostic test
Analysis of the metagenome using faecal samples of participants after acute kidney injury
Bioimpedance analysisDiagnostic test
Estimation of body composition
Patient reported outcome measuresOther
EQ-5D-5L, KSQ, WHO-DAS 2.0, K10
Measurement of physical performanceOther
Hand grip, Short physical performance battery
| Study group | Role | What they receive |
|---|---|---|
| Observational study | Patients 3 months after hospitalised acute kidney injury Receives: 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 Receives: Other: Semi structured interview | |
| Participatory workshops | Individuals with personal or professional experience of acute kidney injury Receives: Other: Participatory workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible patients who agree to participate
Measured: 3 months
The proportion of participants who have all three measurements (eGFR-cystatin, eGFR-creatinine and measured GFR)
Measured: 3 months
Standard deviation of the difference between measured GFR and eGFR-creatinine and eGFR-cystatin
Measured: 3 months
The proportion of patients with eGFR <60ml/min/1.73m2 from eGFR-cystatin compared with eGFR creatinine
Measured: 3 months
Gut microbiome composition
Assessed through metagenomics
Measured: 3 months
Codes and themes related to patient experience after AKI, identified from systematic qualitative analysis of interview transcripts
Measured: 3 - 12 months
Production of a document of recommended next steps through MDT development during participatory workshops
Measured: At completion of third workshop 3 years after enrolment
Secondary outcomes (10)
The mean difference between eGFR-cystatin and eGFR-creatinine
Measured: 3 months
The mean difference between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)
Measured: 3 months
Correlation between eGFR creatinine and eGFR cystatin
Measured: 3 months
Correlation between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)
Measured: 3 months
Bias between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)
Measured: 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)
Measured: 3 months
Correlation of muscle mass with the percentage difference between eGFR-cystatin and eGFR-creatinine
Measured: 3 months
Correlation of physical function with the percentage difference between eGFR-cystatin and eGFR-creatinine
Measured: 3 months
Correlation of patient reported outcomes with the percentage difference between eGFR-cystatin and eGFR-creatinine
Measured: 3 months
Barriers to implementation of recommendations as identified through MDT discussion at participatory workshops
Measured: At completion of third workshop 3 years after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start16 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Nicholas Selby, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569588
- Sponsor's protocol ID
- 25019
- Acronym
- IMPACT-AKI
- Status last verified
- Dec 2025
- First submitted
- 29 Jan 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing will be available on request through the study team and individual applications will be considered.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Assessment After Acute Kidney Injury (AKI)
- ClinicalTrials.gov ID
- NCT07569588
- Acronym / sponsor ID
- IMPACT-AKI / 25019
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, chronic kidney disease, patient reported outcome measures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is creatinine or cystatin a more reliable assessment of kidney function after AKI?
- What are the experiences of patients after AKI?
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational study | – | 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 performancePatients 3 months after hospitalised acute kidney injury |
| Qualitative study | – | Other: Semi structured interviewPatients 3 months after hospitalised acute kidney injury |
| Participatory workshops | – | Other: Participatory workshopIndividuals with personal or professional experience of acute kidney injury |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- Observational study workstream
- Inability to give informed consent
- No baseline creatinine available in previous 12 months
- Pregnancy or breastfeeding
- Current treatment with dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iohexol renal clearance measurementGold standard measurement of glomerular filtration rate. | Diagnostic test | Observational study |
| Cystatin CEstimated GFR using serum cystatin C | Diagnostic test | Observational study |
| CreatinineeGFR from serum creatinine level | Diagnostic test | Observational study |
| Semi structured interviewSemi 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 | Qualitative study |
| Participatory workshopGroup 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. | Other | Participatory workshops |
| Metagenome analysisAnalysis of the metagenome using faecal samples of participants after acute kidney injury | Diagnostic test | Observational study |
| Bioimpedance analysisEstimation of body composition | Diagnostic test | Observational study |
| Patient reported outcome measuresEQ-5D-5L, KSQ, WHO-DAS 2.0, K10 | Other | Observational study |
| Measurement of physical performanceHand grip, Short physical performance battery | Other | Observational study |
Primary outcome
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
Assessed through metagenomics
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing will be available on request through the study team and individual applications will be considered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Selby principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerry Horne Dr, BMBCh (+44 01332 788262, kerry.horne@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eligible patients who agree to participate (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.