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Evaluation of the protective effect of Empagliflozin against contrast-induced nephropathy after percutaneous coronary intervention

Effect of Empagliflozin in preventing contrast-induced acute kidney injury (CI-AKI) in patients undergoing percutaneous coronary intervention (PCI)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220521054950N1
Enrollment
120
Registered
2022-06-15
Start date
2022-07-23
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast induced acute kidney injury. Acute kidney failure, unspecified

Interventions

Intervention 1: Intervention group: Patients will take 10 mg Empagliflozin once daily from the day before PCI and continue for 3 days after that. These prescribed tablets belong to the Abidi company c
is used to prepare the placebo. These compounds are mixed together and pressed with a tablet press with exactly the same mandrel and the same shape as Empagliflozin tablets. Patients will take the pla

Sponsors

National Institute for Research Development of Medical Sciences of Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age. Patients undergoing percutaneous coronary intervention. Patients with glomerular filtration rate (GFR) below 60 ml/min/ 1.73 m2. Patients who filled out an informed written consent form.

Exclusion criteria

Exclusion criteria: Patients with acute myocardial infarction. Patients undergoing hemodialysis. Patients who have received a contrast agent in the last 10 days. Patients taking medications that are associated with an increased risk of acute kidney injury, such as NSAIDs. Patients with known malignancy or active infection. Patients who consume alcohol.

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate: Describes the flow rate of filtered fluid through the kidney and is a measure of kidney function. Timepoint: Before the intervention and 3 days after PCI. Method of measurement: Calculated using the Modification of Diet in Renal Disease formula .

Secondary

MeasureTime frame
Creatinine: is a breakdown product of creatine phosphate from muscle and protein metabolism. It is released at a constant rate by the body (depending on muscle mass). Timepoint: Before the intervention and 3 days after PCI. Method of measurement: Before PCI, 5cc of fasting venous blood samples are taken from the patients for evaluation of the creatinine. The serum sample is separated from the blood and stored at -20 ° C.;Blood urea nitrogen (BUN): is a medical test that measures the amount of urea nitrogen found in the blood. The liver produces urea in the urea cycle as a waste product of the digestion of protein. Timepoint: Before the intervention and 3 days after PCI. Method of measurement: Before PCI, 5cc of fasting venous blood samples are taken from the patients for evaluation of the BUN. The serum sample is separated from the blood and stored at -20 ° C.;Cystatin C: is a protein encoded by the CST3 gene, is mainly used as a biomarker of kidney function. Timepoint: Before the intervention and 3 days after PCI. Method of measurement: Before PCI, 5cc of fasting venous blood samples are taken from the patients for evaluation of the Cystatin C. The serum sample is separated from the blood and stored at -20 ° C.;Pro-brain natriuretic peptide (pro-BNP): is a hormone secreted by cardiomyocytes in the heart ventricles in response to stretching caused by increased ventricular blood volume. Timepoint: Before the intervention and 3 days after PCI. Method of measurement: Before PCI, 5cc of fasting venous blood samples are taken from the patients for evaluation of the pro-BNP. The serum sample is separated from the blood and stored at -20 ° C.;High-sensitivity C-reactive protein (hs-CRP): is an annular pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. Timepoint: Before the intervention and 3 days after PCI. Method of measurement: Before PCI, 5cc of fasting venous blood samples are taken from the patients for evalua

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Sadat Hosseini

Islamic Azad University

zeinabsh20@yahoo.com+98 915 514 0305

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026