SGLT2 Inhibitors Prophylaxis Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease?

Study Overview
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Brief Summary
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We will look for the possible effect of SGLT2i as a single agent to prevent post-contrast Acute Kidney Injury in diabetic kidney disease.

Detailed Description
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Population of Study o Group 1 : st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. o Group 2 : nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily o Group 3 : rd group will receive the SGLT2i empagliflosin 25 mg once daily o Group 4 : thwill receive allopurinol and empagliflosin. Inclusion Criteria : o Age: more than30years, diabetes,diabetic kidney disease,GFR: more than30ml/min/1.73m2 Exclusion Criteria : o Diabetics Patients with GFR less than 30 mL/min/1.73 m2. Sample Size ( number of participants included ) : 800 patients Fayoum University Faculty of Medicine Scientific Research Ethics Committee Methodology in details : The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration. Baseline serum creatinine will be obtained 72 hours before the planned intervention and before administration of any protective protocol and follow-up serum creatinine will be obtained 72 hours and 1 week after contrast administration. The first control group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. Saline should be given by infusion pump to guarantee steady rate of infusion. 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily. 3rd group will receive the SGLT2i empagliflosin 25 mg once daily, and the 4th will receive allopurinol and empagliflosin.

Official Title
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Is SGLT2 Inhibitors a Better Prophylactic Agent Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease? A Multicenter Prospective Randomized Controlled Study

Conditions
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SGLT2i Kideny Protection Against Contrast in Diabetic Kidney

Intervention / Treatment
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* Drug: Empagliflozin 25 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: more than30years, Diabetes, Diabetic kidney disease, GFR: more than30ml/min/1.73m2 Exclusion Criteria: Diabetics Patients with GFR less than 30 mL/min/1.73 m2.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>1st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast | |
| Group 2<br>2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily | |
| Group 3<br>3rd group will receive the SGLT2i empagliflosin 25 mg once daily | Drug: Empagliflozin 25 MG<br>* PAtient will receive empagliflozin 25 mg daily<br>* Other names: SGLT2 inhibitors;|
| Group 4<br>4thwill receive allopurinol and empagliflosin. | Drug: Empagliflozin 25 MG<br>* PAtient will receive empagliflozin 25 mg daily<br>* Other names: SGLT2 inhibitors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGLT2i proves protective effect | SGLT2i shows protected the kidneys against contrast injury | 72hours after contrast | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGLT2i is non inferior to allopurinol | SGLT2i showed noninferiorty whencompared to allopurinol | 72hours after contrast |