Clinical trial NCT06418542: Contrast Nephropathy Associated FFA
Official title: Assessment of the Frequency of Fundus Fluorescein Angiography Relationship With Contrast Nephropathy and Associated Factors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Contrast-induced Nephropathy
Acute Kidney Injury
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Contrast Nephropathy associated FFA
timeFrame: 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University
Study officials:
References: