跳至主要内容
临床试验/NCT06418542
NCT06418542进行中(未招募)4 期

Assessment of the Frequency of Fundus Fluorescein Angiography Relationship With Contrast Nephropathy and Associated Factors

Saglik Bilimleri Universitesi2 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
140
试验地点
2
主要终点
Contrast Nephropathy associated FFA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Contrast Nephropathy associated FFA

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NUR SENA ÇOBAN

Assistant Doctor

Saglik Bilimleri Universitesi

研究点 (2)

Loading locations...

相似试验