EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY

NCT06288529 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 975
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Type2diabetes

Keywords

Sodium-glucose co-transporter inhibitor; post-contrast acute kidney injury; contrast media; diabetes mellitus; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Patients with type 2 diabetes mellitus using SGLT2 inhibitor

Patients with type 2 diabetes mellitus not using SGLT2 inhibitor

Patients with chronic kidney disease mellitus using SGLT2 inhibitor

Patients with chronic kidney disease mellitus not using SGLT2 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total of 975 patients are palanned to be included in our study who underwent coronary artery imaging or percutaneous coronary intervention procedures using CM in three tertiary hospitals. Patient ages between 18 and 75 years and estimated glomerular filtration rates (eGFRs) between 25 and 115 mL/(min•1.73 m2) are palanned to be included in our analyses.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Balikesir Hospital Eduation and Research: lead

Study Sites (1)

University of Health Sciences Balikesir Education and Research Hospital

Balıkesir, 10100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: July 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 1, 2024

Record last verified: 2023-07

Locations

TU (1)