Peripheral arterial disease and chronic kidney disease Circulatory System
Conditions
Interventions
Eligible patients identified by their doctors, radiologists, or any other member of their care team/healthcare professional will be given the patient information sheet prior to their procedure to revi
the serum creatinine (eGFR) value taken as part of the standard of care will be recorded, and the participant will be asked to complete the QoL questionnaires (EQ-5D-5L and SF-36), health care resourc
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 03/12/2025: 1. Age >18 years 2. Scheduled to undergo any revascularisation with an endovascular component 3. Estimated glomerular filtration rate 18 years 2. Undergoing any revascularisation with an endovascular component 3. Estimated glomerular filtration rate <60 ml/min/1.73m2 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Known allergy to iodinated contrast media 2. Individuals already on long-term dialysis at the time of screening 3. An inability to understand the languages in which the trial materials are provided.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Log serum creatinine measured from the blood sample taken at 2, 30 and 90 days (part of the standard of care) after endovascular revascularisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary outcome measure: The volume of iodinated contrast medium used during endovascular revascularization measured using data recorded in the index revascularisation intervention case report form on the day of the intervention (day 0). Other secondary outcome measures: 1. Proportion of participants developing AKI within 2 days (48 hours) of procedure based on the KDIGO definition of AKI-stage 2. Proportion of participants developing Major Adverse Kidney Events (MAKE) by 90-day follow-up. A MAKE event is defined as either death, new requirement for dialysis or worsening kidney function denoted by >25% decline in estimated Glomerular Filtration Rate (eGFR). Baseline eGFR will be defined as the most recent value before the procedure. 3. Time spent as an inpatient (days) since randomisation measured using patient medical records by a 90-day follow-up 4. Pain experienced during the procedure measured using a Visual Analogue Scale (VAS) 5. Quality of Life (QoL) at 90-day follow-up measured using the EQ-5D-5L and SF-36 questionnaires 6. The proportion of revascularisation completed as planned measured using patient medical records at one timepoint 7. Number of surgical or endovascular re-interventions measured using patient medical records by the 90-day follow-up 8. Perceived acceptability, feasibility and factors that may influence the adoption of CO2 during each revascularisation by the practitioners/participants measured using the Theoretical Framework of Acceptability Questionnaire at the 90-day follow-up for patients, and post-procedure (administered within 3 days of the intervention) and cross-sectional questionnaires (administered after few months into recruitment) for practitioners. 9. Costs associated with each procedure (health economic analysis) measured using a Healthcare Resource Use questionnaire over a minimum 90-day period (end of clinical follow-up) | — |
Countries
United Kingdom
Contacts
Public ContactDania Tapia-Aguirre
Outcome results
None listed