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

• Conditions: SGLT2i Kideny Protection Against Contrast in Diabetic Kidney
• Interventions: Drug: Empagliflozin 25 MG

• Registration Number: NCT04853615
• Lead Sponsor: Fayoum University

Brief Summary

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

Population of Study o Group 1 :

1. st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast.

o Group 2 :

2. nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily

o Group 3 :

3. rd group will receive the SGLT2i empagliflosin 25 mg once daily

o Group 4 :

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.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-17
• Study First Submitted QC: 2021-04-17
• Study First Posted: 2021-04-21
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26
• Study Start: 2021-07-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 4	Empagliflozin 25 MG	4thwill receive allopurinol and empagliflosin.
Group 3	Empagliflozin 25 MG	3rd group will receive the SGLT2i empagliflosin 25 mg once daily

Primary Outcome Measures

Name	Time	Method
SGLT2i proves protective effect	72hours after contrast	SGLT2i shows protected the kidneys against contrast injury

Secondary Outcome Measures

Name	Time	Method
SGLT2i is non inferior to allopurinol	72hours after contrast	SGLT2i showed noninferiorty whencompared to allopurinol