Contrast Nephropathy Associated FFA

Phase 4

Active, not recruiting

• Conditions: Contrast-induced Nephropathy; Acute Kidney Injury
• Interventions: Device: use of florescein

• Registration Number: NCT06418542
• Lead Sponsor: Saglik Bilimleri Universitesi

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.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
END	use of florescein	patients who have chronic renal disease
END free	use of florescein	patients who don't have chronic renal disease

Primary Outcome Measures

Name	Time	Method
Contrast Nephropathy associated FFA	48-72 hours	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.

Trial Locations

Locations (1)

Saglik Bilimleri University; 🇹🇷 Istanbul, Turkey