EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY

February 23, 2024 updated by: University of Health Sciences Balikesir Hospital Eduation and Research

PROTECTIVE EFFECT OF SGLT2 INHIBITORS ON POST-CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY IN DIABETIC AND CKD PATIENTS

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

975

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Balıkesir, Turkey, 10100
        • University of Health Sciences Balikesir Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of post-contrast acute kidney injury
Time Frame: Within 48-72 hours following intravenous contrast medium administration.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Balikesir Hospital Eduation and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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