Contrast Nephropathy Associated FFA

NCT06418542 | Active Not Recruiting Phase 4

• 1 other identifier: E-48865165
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

After the use of iodinated contrast agents, there is a risk of developing contrast nephropathy. Limited data in the literature are available on the incidence of contrast nephropathy after fluorescein angiography (FFA), which is an iodine-free organic contrast. Additionally, factors associated with contrast nephropathy after FFA are not clearly understood. Our study aims to evaluate these points.

Conditions

Contrast-induced Nephropathy; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Contrast Nephropathy associated FFA

  Urea and creatinine values will be measured 48-72 hours after FFA . The renal function of these patients one month before FFA will be compared with the renal function 48-72 hours after FFA and the development of contrast nephropathy will be determined based on KDIGO and AKIN criteria.

  48-72 hours

Study Arms (2)

END

OTHER

patients who have chronic renal disease

Device: use of florescein

END free

OTHER

patients who don't have chronic renal disease

Device: use of florescein

Interventions

use of florescein DEVICE

Fluorescein, an organic contrast agent, is used in FFA to detect retinal pathologies.

END; END free

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old. Patients with an indication for FFA. Those who agreed to participate in the study.

You may not qualify if:

• Patients with nephrotoxic drug exposure in the last two weeks
• Patients who underwent imaging management requiring the use of other contrast agents in the last month (such as coronary angiography, CT angiography)
• Patients with unstable hemodynamics
• Patients with obstructive uropathy
• Patients with end-stage renal failure with eGFR\<15
• Patients on a routine hemodialysis program

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

TU (1)