Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flozin.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Acute Kidney Injury, Contrast-Induced Acute Kidney Injury, Percutaneous Coronary Intervention. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study
Overview
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.
Detailed description
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.
Interventions
- Drug Flozin
Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin
Primary outcome measures
- Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI) [Time frame: 0-72 hours]
Secondary outcome measures (6)
- Creatinine change after coronary procedure [Time frame: 0-72 hours]
- eGFR after coronary procedure [Time frame: 0-72 hours]
- Real-life incidence of AKI [Time frame: 0-72 hours]
- incidence of CI-AKI in diabetic patients [Time frame: 0-72 hours]
- incidence of CI-AKI in ACS patients using flozins [Time frame: 0-72 hours]
- incidence of CI-AKI on empagliflozin vs dapagliflozin [Time frame: 0-72 hours]
Eligibility criteria
Inclusion criteria
- all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available
Exclusion criteria
- unavailability of variables required for the analysis, volume
- contrast agent volume <50 mL or >500 mL.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Poland · 1 center
- Collegium Medicum w Bydgoszczy — Bydgoszcz
Identifiers
NCT: NCT07231939 · FLORENCE