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

University of Nottingham

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Other: Semi structured interview; Diagnostic Test: Bioimpedance analysis; Diagnostic Test: Iohexol renal clearance measurement; Diagnostic Test: Metagenome analysis; Other: Participatory workshop; Other: Patient reported outcome measures; Diagnostic Test: Creatinine; Diagnostic Test: Cystatin C; Other: Measurement of physical performance

Study type: Observational

Funder types: Other

Identifiers

NCT07569588

25019

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 3 patient groups

Observational study

Description:

Patients 3 months after hospitalised acute kidney injury

Treatment:

Other: Measurement of physical performance

Diagnostic Test: Creatinine

Diagnostic Test: Cystatin C

Other: Patient reported outcome measures

Diagnostic Test: Metagenome analysis

Diagnostic Test: Iohexol renal clearance measurement

Diagnostic Test: Bioimpedance analysis

Qualitative study

Description:

Patients 3 months after hospitalised acute kidney injury

Treatment:

Other: Semi structured interview

Participatory workshops

Description:

Individuals with personal or professional experience of acute kidney injury

Treatment:

Other: Participatory workshop