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NCT Number: NCT07569588

Improving Patient Assessment After Acute Kidney Injury (AKI)

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

Recruiting

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location status: Recruiting

Location contact

Kerry Horne Dr

CONTACT

[email protected]

01332788262

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Iohexol renal clearance measurement

Diagnostic Test

Gold standard measurement of glomerular filtration rate.

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

Primary outcomes

  1. The proportion of eligible patients who agree to participate

    Time frame: 3 months

  2. The proportion of participants who have all three measurements (eGFR-cystatin, eGFR-creatinine and measured GFR)

    Time frame: 3 months

  3. Standard deviation of the difference between measured GFR and eGFR-creatinine and eGFR-cystatin

    Time frame: 3 months

  4. The proportion of patients with eGFR <60ml/min/1.73m2 from eGFR-cystatin compared with eGFR creatinine

    Time frame: 3 months

  5. Gut microbiome composition

    Time frame: 3 months

    Assessed through metagenomics

  6. Codes and themes related to patient experience after AKI, identified from systematic qualitative analysis of interview transcripts

    Time frame: 3 - 12 months

  7. 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 outcomes

  1. The mean difference between eGFR-cystatin and eGFR-creatinine

    Time frame: 3 months

  2. The mean difference between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)

    Time frame: 3 months

  3. Correlation between eGFR creatinine and eGFR cystatin

    Time frame: 3 months

  4. Correlation between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)

    Time frame: 3 months

  5. Bias between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)

    Time frame: 3 months

  6. 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

  7. Correlation of muscle mass with the percentage difference between eGFR-cystatin and eGFR-creatinine

    Time frame: 3 months

  8. Correlation of physical function with the percentage difference between eGFR-cystatin and eGFR-creatinine

    Time frame: 3 months

  9. Correlation of patient reported outcomes with the percentage difference between eGFR-cystatin and eGFR-creatinine

    Time frame: 3 months

  10. Barriers to implementation of recommendations as identified through MDT discussion at participatory workshops

    Time frame: At completion of third workshop 3 years after enrolment

Other outcomes

  1. Safety Outcomes

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

    • Adverse events spontaneously reported during the study
    • Discontinuation due to adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Kerry Horne Dr, BMBCh

CONTACT

[email protected]

+44 01332 788262

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Registry information

Acronym: IMPACT-AKI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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