FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available
排除标准
- •unavailability of variables required for the analysis, volume
- •contrast agent volume <50 mL or >500 mL.
研究组 & 干预措施
Patients using any flozin at the time of coronary intervention
Patients who underwent percutaneous coronary procedures while using empagliflozin or dapagliflozin in a standard 10 mg daily dose
干预措施: Flozin (Drug)
结局指标
主要结局
Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI)
时间窗: 0-72 hours
Occurrence of CI-AKI defined as an increase in serum creatinine concentration of ≥0.5 mg/dL (44.2 μmol/L) or \>25% compared with baseline within 72 h after intravascular administration a contrast medium agent
次要结局
- Creatinine change after coronary procedure(0-72 hours)
- eGFR after coronary procedure(0-72 hours)
- Real-life incidence of AKI(0-72 hours)
- incidence of CI-AKI in diabetic patients(0-72 hours)
- incidence of CI-AKI in ACS patients using flozins(0-72 hours)
- incidence of CI-AKI on empagliflozin vs dapagliflozin(0-72 hours)
研究者
Jacek Kubica
Professor
Collegium Medicum w Bydgoszczy