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NCT Number: NCT06760650

Fluorescein Angiography 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.

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Key information

Conditions

Chronic Kidney Disease Stage 4 Acute Kidney Injury Chronic Disease Chronic Kidney Disease Stage 3B Chronic Kidney Disease Stage 5 Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluorescein Angiography Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Saint Joseph University of Beirut

Beirut, 56100, Lebanon

Location contact

Anthony NOHRA

SUB_INVESTIGATOR

Dania CHELALA, M.D.

CONTACT

[email protected]

Mabel AOUN, M.D., M.P.H.

CONTACT

[email protected]

+9613351588

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescein angiography

Diagnostic Test

Fluorescein angiography

Other names: Fluorescein fundus angiography

Primary outcomes

  1. Change in serum creatinine

    Time frame: At day 4

    Change in serum creatinine from baseline to day 4

Secondary outcomes

  1. Long-term change in serum creatinine

    Time frame: 3 months

    Change in serum creatinine from baseline to end of the third month

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony NOHRA, Medical Student

CONTACT

[email protected]

Mabel AOUN, M.D., M.P.H.

CONTACT

[email protected]

+9613351588

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Acronym: Fluo-AKI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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