Contrast Nephropathy Associated FFA

NCT ID: NCT06418542

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-01

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.

Detailed Description

It is known that patients are at risk of developing contrast nephropathy after FFA with iodinated contrast media. However, although it is known that contrast nephropathy may develop after FFA with fluorescein, a non-iodinated organic contrast agent, there is very limited data in the literature.

In this study, we aimed to determine the incidence of contrast nephropathy after FFA for retinopathy evaluation and to evaluate the associated factors (age, gender, diabetes mellitus, hypertension, chronic kidney disease, baseline renal function, medications, etc.). Our study was planned prospectively. Patients over the age of 18 years who applied to Prof. Dr. Cemil Taşcıoğlu City Hospital Eye Clinic as outpatients and who did not meet the exclusion criteria and agreed to participate in the study will be included in our study. Age, gender, demographic, clinical and laboratory data of these patients will be recorded from the patient file and hospital data processing system. The definition of contrast nephropathy is defined as an increase in serum creatinine (SCr) ≥0.5 mg/dL or more than 25% of the baseline value in the study titled "Contrast-induced Kidney Injury:Focus on Modifiable Risk Factorsand Prophylactic Strategies", "Risk of nephropathy after intravenous administration of contrast material: a critical literature analysis. In this study, an increase of 0.3 mg/dL in serum creatinine within 48 hours after contrast was accepted. The definition of contrast nephropathy will be evaluated separately as both an increase of 0.5 mg/dl or 25% increase in creatinine value compared to baseline and an increase of 0.3 mg/dl compared to baseline. In this way, there are studies in which the frequency of contrast nephropathy was evaluated separately according to both criteria in the same study.

Conditions

Contrast-induced Nephropathy; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

END

patients who have chronic renal disease

Group Type: OTHER

use of florescein

Intervention Type: DEVICE

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

END free

patients who don't have chronic renal disease

Group Type: OTHER

use of florescein

Intervention Type: DEVICE

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

Interventions

use of florescein

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

NUR SENA ÇOBAN

Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saglik Bilimleri University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-48865165

Identifier Type: -

Identifier Source: org_study_id