Contrast Nephropathy Associated FFA

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06418542
• Other study ID #: E-48865165
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-induced Nephropathy
• Kidney Diseases

Intervention

Device:
• use of florescein
Fluorescein, an organic contrast agent, is used in FFA to detect retinal pathologies.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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