A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Launched by UNIVERSITY OF LEIPZIG · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called the MAKE trial, is looking to see if using a special method with Carbon Dioxide (CO2) instead of traditional contrast dye can help protect the kidneys during a specific type of surgery called peripheral vascular intervention (PVI). This trial is especially important for patients who have peripheral vascular diseases and are at risk of kidney problems due to the use of contrast dye. The main goal is to find out if this CO2 method can prevent serious kidney issues for up to 90 days after the procedure.

To be part of this study, participants should be adults aged 18 or older who have symptoms of peripheral arterial disease and are scheduled for a PVI. They should also be at a higher risk for kidney injury based on certain criteria, such as their kidney function being below a certain level. People who have severe kidney problems, certain medical conditions, or who are undergoing specific treatments may not be eligible. If you join the trial, you will be closely monitored during your procedure and afterward to ensure your safety and health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) and/or chronic symptoms (Rutherford clinical categories 3-6)
• • 2. Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions
• • 3. Increased risk of CA-AKI identified by a baseline risk score of ≥ 5 points based on a published dedicated PVI risk score and a pre-angiographic estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m²
• • 4. Both angiographic strategies seem feasible at the investigator's discretion
• • 5. Age 18 years or older
• • 6. Written informed consent
• Exclusion Criteria:
• • 1. Very agitated patients
• • 2. Patients with planned full anaesthesia during procedure
• • 3. Patients with a life-expectancy less than one year
• • 4. Patients confined to bed that are completely non-ambulatory
• • 5. Known acute renal failure or known unstable renal function as evidenced by a recent increase in serum creatinine (SCr) of \> 0.5 mg/dl or \> 25% within 7 days
• • 6. Iodinated contrast medium exposure within 7 days prior to procedure with change in SCr ≥ 0.1 mg/dl on two SCr measures ≥ 24 h apart
• • 7. Advanced chronic kidney disease (CKD) with an eGFR \< 30 ml/min/1.73m² and/or dialysis
• • 8. Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent
• • 9. Acute or chronic pulmonary disease requiring oxygen therapy
• • 10. Patients with known patent foramen ovale or atrial septal defect
• • 11. Patients with planned nitrous oxide anaesthesia during intervention
• • 12. Patients with manifest hyperthyroidism or manifest thyrotoxicosis
• • 13. Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure
• • 14. Patients with decompensated heart failure
• • 15. Patients with manifest tetany
• • 16. Planned further procedure with a need for \> 10 ml of iodinated contrast medium (CM) in any location (e.g., CT scan, coronary angiography) within a period of 90 days
• • 17. Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure
• • 18. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) until day 30 after PVI.
• • 19. Participation in other interventional trials. Exceptions are described in the trial protocol.
• • 20. Suspected lack of compliance
• • 21. Pregnant or nursing women