Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 3B; Chronic Kidney Disease Stage 5; Diabetes Mellitus; Fluorescein Angiography; Acute Kidney Injury

• Registration Number: NCT06760650
• Lead Sponsor: Saint-Joseph University

Brief Summary

Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.

Detailed Description

This study will assess the change in serum creatinine in patients with diabetes and advanced chronic kidney disease, after a fluorescein angiography. This is a before and after study that will include 35 patients from the department of ophtalmology over 6 months with a total follow-up for 3 months.

Study Timeline

• Study First Submitted: 2024-12-26
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study Start: 2025-01-07
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-10-10
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• >18 years old with type 2 or type 1 diabetes and chronic kidney disease stage 3b to 5 (eGFR<45 mL/min/1.73 m2)

Exclusion Criteria

• Patients who do not give their consent
• Patients who are allergic to fluorescein
• Patients who are on dialysis
• Patients who had fever, vomiting, diarrhea or any dehydration 48 hours before the intervention
• Patients who had a treatment modification one week before the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in serum creatinine	At day 4	Change in serum creatinine from baseline to day 4

Secondary Outcome Measures

Name	Time	Method
Long-term change in serum creatinine	3 months	Change in serum creatinine from baseline to end of the third month

Trial Locations

Locations (1)

Faculty of Medicine, Saint Joseph University of Beirut; 🇱🇧 Beirut, Lebanon