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| Name | Class |
|---|---|
| Cairo University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 1st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast | ||
| Group 2 | 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily | ||
| Group 3 | 3rd group will receive the SGLT2i empagliflosin 25 mg once daily |
| |
| Group 4 | 4thwill receive allopurinol and empagliflosin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | PAtient will receive empagliflozin 25 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| SGLT2i proves protective effect | SGLT2i shows protected the kidneys against contrast injury | 72hours after contrast |
| Measure | Description | Time Frame |
|---|---|---|
| SGLT2i is non inferior to allopurinol | SGLT2i showed noninferiorty whencompared to allopurinol | 72hours after contrast |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A Hammad, MD | Contact | +201001574639 | aah12@fayoum.edu.eg | |
| Ahmed Fayed, MD | Contact | dr.fayed@gmail.com |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| D045505 | Physiological Effects of Drugs |