Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease (Fluo-AKI)

January 3, 2025 updated by: Mabel Aoun, Saint-Joseph University

Fluorescein-Induced Acute Kidney Injury in Patients With Diabetes and Chronic Kidney Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lebanon
      • Beirut, Lebanon, 56100
        • Faculty of Medicine, Saint Joseph University of Beirut
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anthony NOHRA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluorescein angiography
Assessing serum creatinine before and after fluorescein angiography
Diagnostic test: Fluorescein angiography
Fluorescein angiography
Other Names:
  • Fluorescein fundus angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum creatinine
Time Frame: At day 4
Change in serum creatinine from baseline to day 4
At day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term change in serum creatinine
Time Frame: 3 months
Change in serum creatinine from baseline to end of the third month
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Joseph University

Investigators

  • Principal Investigator: Mabel AOUN, M.D., M.P.H., Faculty of Medicine, Saint Joseph University of Beirut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 7, 2025

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

October 10, 2025

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEHDF 2587
  • Tfem-2025-79 (Other Identifier: Faculty of Medicine, Saint Joseph University of Beirut)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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