Improving Patient Assessment After Acute Kidney Injury (AKI)

ConditionAcute Kidney Injury

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorUniversity of Nottingham

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability to give informed consent

No baseline creatinine available in previous 12 months

Pregnancy or breastfeeding

Current treatment with dialysis

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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 intervention
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 intervention
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 intervention
EQ-5D-5L, KSQ, WHO-DAS 2.0, K10
Measurement of physical performance
Other intervention
Hand grip, Short physical performance battery

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: Observational study7 interventions

Group B: Qualitative study1 intervention

Group C: Participatory workshops1 intervention

Trial outcomes

Primary outcomes

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

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

Other outcomes

Safety Outcomes

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

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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