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

NCT07891988 | Active Not Recruiting DMC

• 1 other identifier: 0980
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Chronic Kidney Diseases; Acute Kidney Injury

Keywords

Nephrotoxic; Endovascular; Revascularisation; Acute kidney injury; Iodine-based contrast medium; Carbon dioxide; Peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• Renal Function: Log Serum Creatinine

  Assessment of short and medium-term renal decline by measuring serum creatinine from blood samples processed at local pathology laboratories. Unit of Measure: log(µmol/L). Renal decline or "worsening of kidney function" is defined as a \>25% decline in the estimated Glomerular Filtration Rate (eGFR) from the baseline assessment. The baseline eGFR is defined as the most recent value recorded prior to the procedure. Additionally, the trial measures short and medium-term renal decline by tracking changes in Log serum creatinine at 2, 30, and 90 days post-procedure, and evaluates the onset of Acute Kidney Injury (AKI) based on the KDIGO criteria.

  2, 30, and 90 days after endovascular revascularisation

Secondary Outcomes (11)

• Volume of iodinated contrast medium used

  Intraoperative (during the index procedure)

• Incidence of Acute Kidney Injury (AKI)

  Within 2 days (48 hours) of the procedure

• Proportion of participants developing Major Adverse Kidney Events (MAKE)

  By 90 day post index procedure follow-up

• Inpatient stay duration

  By 90 day post index procedure follow-up

• Pain experienced during the procedure

  During the index procedure (measured at the first and final angiogram)

Study Arms (2)

Iodine contrast medium

ACTIVE COMPARATOR

Standard of care

Other: Iodinated contrast medium

CO2 automated injector contrast medium

EXPERIMENTAL

CO2 automated injector

Other: CO2 automated injector contrast medium

Interventions

Iodinated contrast medium OTHER

Standard of care iodinated contrast medium used by NHS trusts across the UK for endovascular revascularisation.

Iodine contrast medium

CO2 automated injector contrast medium OTHER

Carbon dioxide via an automated injector contrast medium

Also known as: Angiodroid

CO2 automated injector contrast medium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leicester: lead
• St George's, University of London: collaborator
• University of Nottingham: collaborator
• King's College London: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (6)

University Hospital of Leicester NHS Trust

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Hull University Hospitals Teaching NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0RE, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Renal Insufficiency, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Athanasios Saratzis

  NIHR Leicester Biomedical Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: October 23, 2026
• Study Start: February 13, 2025
• Primary Completion: October 12, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)