Идёт набор NCT06656988

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

Фаза III С лечением Peripheral Vascular Diseases Kidney Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: CO2, Iodinated Contrast Media (ICM).
Кому может быть актуально: Состояния в реестре: Peripheral Vascular Diseases, Kidney Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

Препарат CO2
CO2 will be used as contrast medium sparing strategy during peripheral angiography
Препарат Iodinated Contrast Media (ICM)
Iodinated contrast medium will be used as in routine care during peripheral angiography

Первичные конечные точки

MAKE 90 [Срок оценки: From the day of the peripheral vascular intervention (day 0) to day 90]

Критерии участия

Критерии включения

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

Критерии исключения

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