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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCollegium Medicum w Bydgoszczy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

unavailability of variables required for the analysis, volume

contrast agent volume <50 mL or >500 mL.

Trial population

Retrospective analysis of data obtained from patients hospitalized between 2020 and 2025 in the Department of Cardiology and Internal Medicine, who underwent coronary angiography or PCI. 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

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Flozin

    Drug

    Patients who underwent percutaneous coronary interventions while using empagliflozin or dapagliflozin

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: Patients using any flozin at the time of coronary intervention1 intervention
Group B: Patients not using any flozin0 interventions

Trial outcomes

Primary outcomes

1

Occurrence of Contrast-Induced Acute Kidney Injury (CI-AKI)

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

Time frame
0-72 hours

Secondary outcomes

1

Creatinine change after coronary procedure

Change in serum creatinine concentration before and after the index procedure

Time frame
0-72 hours
2

eGFR after coronary procedure

Change in eGFR before and after the index procedure

Time frame
0-72 hours
3

Real-life incidence of AKI

the true incidence of CI-AKI in real-world clinical setting

Time frame
0-72 hours
4

incidence of CI-AKI in diabetic patients

the effect of SGLTi on the occurrence of CI-AKI in patients with and without type 2 diabetes mellitus

Time frame
0-72 hours

Other outcomes

Sponsors and contacts

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