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NCT07891988Active, not recruiting

Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

This research trial will test whether using carbon dioxide as a contrast medium during surgery to open blocked leg arteries can prevent kidney injury. One in five people over 55 in the UK suffer with narrowing or blockages in their leg arteries, which is called peripheral arterial disease. It leads to poor leg circulation, which can cause leg gangrene or infection. Sometimes this may even lead to major lower limb amputation. To prevent this from happening, the affected arteries can be opened using endovascular revascularisation. These procedures are the most common artery surgeries in the NHS. To be able to perform these procedures, doctors use an iodine-based contrast medium (dye) injected in the artery, which can negatively affect kidney function. Instead of the usual dye that causes kidney problems, carbon dioxide can be used as it does not damage the kidneys. No previous randomised controlled trial, however, has tested whether using carbon dioxide via automated injectors does indeed protect the kidneys in these procedures. This research will take place in at least six NHS hospitals in the UK. People with peripheral arterial disease and chronic kidney disease who are having a procedure to open their arteries will be asked to take part. Participants will be randomly chosen to have the procedure with carbon dioxide or with standard iodine-based contrast medium. The investigators will then perform blood tests to measure serum creatinine on the 2nd, 30th, and 90th day after the procedure to compare kidney function between the two groups. The investigators will also compare the volume of iodine-based contrast medium used. The study will also include qualitative research into how the hospital staff performing the intervention feel, as well as how participants found the procedure with carbon dioxide.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
184 (actual)
First submitted
10 Jul 2024
Start date
13 Feb 2025
Primary completion date
12 Oct 2026
Lead sponsor
University of Leicester
NCT number
NCT07891988

What you commit to

  • Study type: Interventional
  • Participants enrolled: 184
  • From 13 Feb 2025 to the primary completion date, 12 Oct 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known allergy to iodinated contrast media

Other

  • Individuals already on long-term dialysis at time of screening
  • An inability to understand the languages in which the trial materials are provided.

Who the study is looking for

  • Age \> 18 years
  • Undergoing any revascularisation with an endovascular component
  • Estimated glomerular filtration rate \<60ml/min/1.73m2 (two separate eGFR readings \<60 ml/min/1.73m² in the last three months) .
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hull University Hospitals Teaching NHS Trust
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HullUnited KingdomUnknown status
University Hospital of Leicester NHS Trust
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LeicesterUnited KingdomUnknown status
Guy's and St Thomas' NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
St. George's University Hospitals NHS Foundation Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Manchester University NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
University Hospitals of North Midlands NHS Trust
Coordinator of this site? Confirm its status
Stoke-on-TrentUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.