A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CO2, Iodinated Contrast Media (ICM).
- Who it may be relevant to
- Registry conditions: Peripheral Vascular Diseases, Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Contrast Medium Sparing Strategy Using Automated Carbon Dioxide Injection During PERIpheral Vascular Interventions for PREVENTion of Major Adverse Kidney Events (MAKE): the PeriPREVENT Randomized Controlled Trial
Overview
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
- Drug CO2
CO2 will be used as contrast medium sparing strategy during peripheral angiography - Drug Iodinated Contrast Media (ICM)
Iodinated contrast medium will be used as in routine care during peripheral angiography
Primary outcome measures
- MAKE 90 [Time frame: From the day of the peripheral vascular intervention (day 0) to day 90]
Eligibility criteria
Inclusion criteria
- 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)
- Planned peripheral vascular intervention of infrainguinal arteries due to femoropopliteal and/or infrapopliteal lesions
- 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
- Both angiographic strategies seem feasible at the investigator's discretion
- Age 18 years or older
- Written informed consent
Exclusion criteria
- Very agitated patients
- Patients with planned full anaesthesia during procedure
- Patients with a life-expectancy less than one year
- Patients confined to bed that are completely non-ambulatory
- 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
- 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
- Advanced chronic kidney disease (CKD) with an eGFR \< 30 ml/min/1.73m² and/or dialysis
- Current use of nephrotoxic agents (aminoglycoside antibiotics, sulfonamides, amphotericin B, or pentamidine), or an active chemotherapy agent
- Acute or chronic pulmonary disease requiring oxygen therapy
- Patients with known patent foramen ovale or atrial septal defect
- Patients with planned nitrous oxide anaesthesia during intervention
- Patients with manifest hyperthyroidism or manifest thyrotoxicosis
- Known allergies or hypersensitivity to iodinated contrast media that cannot be adequately pre-treated prior to index procedure
- Patients with decompensated heart failure
- Patients with manifest tetany
- 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
- Any surgical procedure (except minor amputations) or intervention performed within 30 days prior to or planned within 90 days post index procedure
- 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.
- Participation in other interventional trials. Exceptions are described in the trial protocol.
- Suspected lack of compliance
- Pregnant or nursing women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 9 centers
- Kreiskrankenhaus Alsfeld — Alsfeld
- Universitäts-Herzzentrum Freiburg-Bad Krozingen — Bad Krozingen
- Universitätsklinikum Bonn — Bonn
- Klinikum Chemnitz gGmbH — Chemnitz
- DIAKO Krankenhaus gGmbH Flensburg — Flensburg
- MVZ CCB Frankfurt und Main-Taunus GbR — Frankfurt a.M.
- Universitätsklinikum Leipzig — Leipzig
- Klinikum rechts der Isar der Technischen Universität München — München
- … and 1 more center
Austria · 2 centers
- Tirol Kliniken Innsbruck — Innsbruck
- Universitätsklinik für Innere Medizin II — Vienna
Identifiers
NCT: NCT06656988 · PeriPREVENT · 2024-512876-37-00