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Improving Patient Assessment After Acute Kidney Injury (AKI) (IMPACT-AKI)

1. maj 2026 opdateret af: University of Nottingham

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
    • Derbyshire
      • Derby, Derbyshire, Det Forenede Kongerige, DE22 3DT
        • Rekruttering
        • University Hospitals of Derby and Burton NHS Foundation Trust
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Observational study
Patients 3 months after hospitalised acute kidney injury
Diagnostisk test: Iohexol renal clearance measurement
Gold standard measurement of glomerular filtration rate.
Diagnostisk test: Cystatin C
Estimated GFR using serum cystatin C
Diagnostisk test: Creatinine
eGFR from serum creatinine level
Diagnostisk test: Metagenome analysis
Analysis of the metagenome using faecal samples of participants after acute kidney injury
Diagnostisk test: Bioimpedance analysis
Estimation of body composition
Andet: Patient reported outcome measures
EQ-5D-5L, KSQ, WHO-DAS 2.0, K10
Andet: Measurement of physical performance
Hand grip, Short physical performance battery
Qualitative study
Patients 3 months after hospitalised acute kidney injury
Andet: 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.
Participatory workshops
Individuals with personal or professional experience of acute kidney injury
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Outcomes
Tidsramme: 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
From enrolment until the end of study visits (from 3 to 12 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Nottingham

Samarbejdspartnere

University Hospitals of Derby and Burton NHS Foundation Trust

Efterforskere

  • Ledende efterforsker: Nicholas Selby, University of Nottingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. februar 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. oktober 2029

Datoer for studieregistrering

Først indsendt

29. januar 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25019

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

IPD sharing will be available on request through the study team and individual applications will be considered.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut nyreskade

Kliniske forsøg med Iohexol renal clearance measurement

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner