Clinical trial NCT06656988: A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Peripheral Vascular Diseases
Kidney Diseases
Keywords: carbon dioxide
contrast medium
iodinated contrast medium
CA-AKI
angiography
angioplasty
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 1960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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) \&lt; 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 \&gt; 0.5 mg/dl or \&gt; 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 \&lt; 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 \&gt; 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 outcomes:
measure: MAKE 90
timeFrame: From the day of the peripheral vascular intervention (day 0) to day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Tirol Kliniken Innsbruck
city: Wien
country: Austria
facility: Universitätsklinik für Innere Medizin II
city: Alsfeld
country: Germany
facility: Kreiskrankenhaus Alsfeld
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen
city: Frankfurt a.M.
country: Germany
facility: MVZ CCB Frankfurt und Main-Taunus GbR
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Sonneberg
country: Germany
facility: MEDINOS Kliniken des Landkreises Sonneberg GmbH
city: Weinheim
country: Germany
facility: GRN - Klinik Weinheim
Study officials:
affiliation: University Leipzig
name: Sabine Steiner, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: