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

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

Sponsors

Lead Sponsor: Fayoum University

Collaborator: Cairo University

Source 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.

Overall Status Not yet recruiting
Start Date 2021-07-01
Completion Date 2024-08-01
Primary Completion Date 2024-07-01
Study Type Observational
Primary Outcome
Measure Time Frame
SGLT2i proves protective effect 72hours after contrast
Secondary Outcome
Measure Time Frame
SGLT2i is non inferior to allopurinol 72hours after contrast
Enrollment 800
Condition
Intervention

Intervention Type: Drug

Intervention Name: Empagliflozin 25 MG

Description: PAtient will receive empagliflozin 25 mg daily

Other Name: SGLT2 inhibitors

Eligibility

Sampling Method:

Probability Sample

Criteria:

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.

Gender:

All

Minimum Age:

30 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Ahmed A Hammad, MD

Phone: +201001574639

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fayoum University

Investigator Full Name: Ahmed Abdelkawi Hammad

Investigator Title: Lecturer of internal medicine

Has Expanded Access No
Condition Browse
Arm Group

Label: Group 1

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

Label: Group 2

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

Label: Group 3

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

Label: Group 4

Description: 4thwill receive allopurinol and empagliflosin.

Patient Data Undecided
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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