Recruiting
Phase 3
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
Condition(s) studied
Peripheral Vascular DiseasesKidney Diseases
Investigational drug(s) / intervention(s)
CO2Iodinated Contrast Media (ICM)
CO2: CO2 will be used as contrast medium sparing strategy during peripheral angiography
Iodinated Contrast Media (ICM): Iodinated contrast medium will be used as in routine care during peripheral angiography
Study summary
The primary objective of the trial is to evaluate if an iodinated contrast medium sparing strategy using automated Carbon Dioxide (CO2) Injection prevents Major Adverse Kidney Events up to 90 days (MAKE90) in patients at moderately elevated risk for contrast-associated acute kidney injury (CA-AKI) undergoing infrainguinal peripheral vascular interventions (PVI).
Eligibility
Inclusion Criteria:
1. Symptomatic peripheral arterial disease presenting with either acute symptoms (Rutherford clinical categories I-IIb) or chronic symptoms (Fontaine stages IIb-IV or Rutherford clinical categories 2-6)
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
Primary outcome measure(s)
- MAKE 90 — From the day of the peripheral vascular intervention (day 0) to day 90
major adverse kidney events
Trial sites (11)
| Facility | City | Region | Status |
| Tirol Kliniken Innsbruck |
Innsbruck |
Austria |
Recruiting |
| Universitätsklinik für Innere Medizin II |
Vienna |
Austria |
Recruiting |
| Kreiskrankenhaus Alsfeld |
Alsfeld |
Germany |
Recruiting |
| Universitäts-Herzzentrum Freiburg-Bad Krozingen |
Bad Krozingen |
Germany |
Recruiting |
| Universitätsklinikum Bonn |
Bonn |
Germany |
Not Yet Recruiting |
| Klinikum Chemnitz gGmbH |
Chemnitz |
Germany |
Not Yet Recruiting |
| DIAKO Krankenhaus gGmbH Flensburg |
Flensburg |
Germany |
Not Yet Recruiting |
| MVZ CCB Frankfurt und Main-Taunus GbR |
Frankfurt a.M. |
Germany |
Recruiting |
| Universitätsklinikum Leipzig |
Leipzig |
Germany |
Recruiting |
| Klinikum rechts der Isar der Technischen Universität München |
München |
Germany |
Recruiting |
| GRN - Klinik Weinheim |
Weinheim |
Germany |
Recruiting |
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