Идёт набор NCT07231939

Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI

— Наблюдательное Coronary Artery Disease Acute Kidney Injury Contrast-Induced Acute Kidney Injury Percutaneous Coronary Intervention

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: Flozin.
Кому может быть актуально: Состояния в реестре: Coronary Artery Disease, Acute Kidney Injury, Contrast-Induced Acute Kidney Injury, Percutaneous Coronary Intervention. 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: Польша
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

FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study

Обзор

All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion. The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available. The primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.

Подробное описание

The use of radiological imaging methods requiring iodine-based contrast media (ICM) has been steadily increasing in recent years. Contrast-induced acute kidney injury (CI-AKI), formerly referred to as contrast-induced nephropathy (CIN), is one of the most common causes of acute kidney injury in patients undergoing diagnostic or therapeutic procedures involving ICM.

The study was designed as a retrospective, single-centre, cross-sectional, cohort, case-control study. All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion. The final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available.

The primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.

The analysis of the baseline characteristics of the study population is planned.

Based on the results of the study, a meta-analysis combining the results of previously published studies with those of the present study will be performed.

Key variables to be analyzed: type and volume of ICM; serum creatinine concentration at baseline, 24 h, 48 h, and 72 h after the procedure; eGFR at baseline, 24 h, 48 h, and 72 h; use of SGLT2i within 3 days prior to the procedure; long-term use of SGLT2i; type of SGLT2i administered.

Вмешательства

Препарат Flozin
Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin

Первичные конечные точки

Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI) [Срок оценки: 0-72 hours]

Вторичные конечные точки (6)

Creatinine change after coronary procedure [Срок оценки: 0-72 hours]
eGFR after coronary procedure [Срок оценки: 0-72 hours]
Real-life incidence of AKI [Срок оценки: 0-72 hours]
incidence of CI-AKI in diabetic patients [Срок оценки: 0-72 hours]
incidence of CI-AKI in ACS patients using flozins [Срок оценки: 0-72 hours]
incidence of CI-AKI on empagliflozin vs dapagliflozin [Срок оценки: 0-72 hours]

Критерии участия

Критерии включения

all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available