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

Fayoum University

Status: Not yet enrolling

Conditions: SGLT2i Kideny Protection Against Contrast in Diabetic Kidney

Treatments: Drug: Empagliflozin 25 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04853615

EC 2119

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 4 patient groups

Group 1

Description:

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

Group 2

Description:

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

Group 3

Description:

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

Treatment:

Drug: Empagliflozin 25 MG

Group 4

Description:

4thwill receive allopurinol and empagliflosin.

Treatment:

Drug: Empagliflozin 25 MG