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
1 other identifier
observational
800
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedApril 26, 2021
April 1, 2021
3 years
April 17, 2021
April 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
SGLT2i proves protective effect
SGLT2i shows protected the kidneys against contrast injury
72hours after contrast
Secondary Outcomes (1)
SGLT2i is non inferior to allopurinol
72hours after contrast
Study Arms (4)
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.
Interventions
PAtient will receive empagliflozin 25 mg daily
Eligibility Criteria
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
You may qualify if:
- Age: more than30years, Diabetes, Diabetic kidney disease, GFR: more than30ml/min/1.73m2
You may not qualify if:
- Diabetics Patients with GFR less than 30 mL/min/1.73 m2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fayoum Universitylead
- Cairo Universitycollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of internal medicine
Study Record Dates
First Submitted
April 17, 2021
First Posted
April 21, 2021
Study Start
July 1, 2021
Primary Completion
July 1, 2024
Study Completion
August 1, 2024
Last Updated
April 26, 2021
Record last verified: 2021-04