Actively Recruiting
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
Led by University of Leipzig · Updated on 2026-03-23
1960
Participants Needed
11
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Tirol Kliniken Innsbruck
Innsbruck, Austria
Actively Recruiting
2
Universitätsklinik für Innere Medizin II
Vienna, Austria
Actively Recruiting
3
Kreiskrankenhaus Alsfeld
Alsfeld, Germany
Actively Recruiting
4
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany
Actively Recruiting
5
Universitätsklinikum Bonn
Bonn, Germany, 53127
Not Yet Recruiting
6
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Not Yet Recruiting
7
DIAKO Krankenhaus gGmbH Flensburg
Flensburg, Germany, 24939
Not Yet Recruiting
8
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt a.M., Germany
Actively Recruiting
9
Universitätsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
10
Klinikum rechts der Isar der Technischen Universität München
München, Germany
Actively Recruiting
11
GRN - Klinik Weinheim
Weinheim, Germany
Actively Recruiting
Research Team
S
Sabine Steiner, Prof Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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