Chronic Kidney Diseases Clinical Trial
Official title:
PROTECTIVE EFFECT OF SGLT2 INHIBITORS ON POST-CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY IN DIABETIC AND CKD PATIENTS
NCT number | NCT06288529 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2023 |
Est. completion date | January 31, 2024 |
Verified date | July 2023 |
Source | University of Health Sciences Balikesir Hospital Eduation and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking. In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI.
Status | Completed |
Enrollment | 975 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients who underwent coronary artery imaging or percutaneous coronary intervention procedures using contrast media - Patient ages were between 18 and 75 years - Estimated glomerular filtration rates (eGFRs) between 25 and 115 Exclusion Criteria: - Patients with acute myocardial infarction, acute renal injury, history of kidney transplantation, severe heart failure (HF, New York Heart Association IV), malignancy, also patients who received other PC-AKI preventive medications like as N-acetylcysteine, sodium bicarbonate, or incomplete medical records were excluded from the analyses. |
Country | Name | City | State |
---|---|---|---|
Turkey | University of Health Sciences Balikesir Education and Research Hospital | Balikesir |
Lead Sponsor | Collaborator |
---|---|
University of Health Sciences Balikesir Hospital Eduation and Research |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of post-contrast acute kidney injury | The impairment of renal function which is measured as either a 25% rise in serum creatinine level from baseline or an increase of 0.5 mg/dL (44 µmol/L) in absolute serum creatinine level. | Within 48-72 hours following intravenous contrast medium administration. |
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