Peripheral Vascular Diseases, Kidney Diseases
Conditions
Keywords
carbon dioxide, contrast medium, iodinated contrast medium, CA-AKI, angiography, angioplasty
Brief 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).
Detailed description
PeriPREVENT is a prospective, multi-centre, controlled, open-label, 1:1 randomized superiority trial with two parallel groups. In the intervention group patients will undergo a routine peripheral angiographic intervention (PVI) using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patient's intolerability of CO2 angiography. The control intervention is routine PVI using iodinated contrast media (CM) as standard of care. All patients are followed up until 12 months after the PVI.
Interventions
DRUGCO2
CO2 will be used as contrast medium sparing strategy during peripheral angiography
Iodinated contrast medium will be used as in routine care during peripheral angiography
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAKE 90 | From the day of the peripheral vascular intervention (day 0) to day 90 | major adverse kidney events |
Countries
Austria, Germany
Contacts
CONTACTSabine Steiner, Prof Dr
PRINCIPAL_INVESTIGATORSabine Steiner, Prof Dr
University Leipzig
Outcome results
None listed