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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
Turkey University of Health Sciences Balikesir Education and Research Hospital Balikesir

Sponsors (1)

Lead Sponsor Collaborator
University of Health Sciences Balikesir Hospital Eduation and Research

Country where clinical trial is conducted

Turkey, 

Outcome

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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