Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418542
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Contrast Nephropathy Associated FFA
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
Official Title:
Assessment of the Frequency of Fundus Fluorescein Angiography Relationship With Contrast Nephropathy and Associated Factors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 mgdL or more than 25 of the baseline value in the study titled Contrast-induced Kidney InjuryFocus 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 03 mgdL in serum creatinine within 48 hours after contrast was accepted The definition of contrast nephropathy will be evaluated separately as both an increase of 05 mgdl or 25 increase in creatinine value compared to baseline and an increase of 03 mgdl 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
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 05 mgdL or more than 25 of the baseline value in the study titled Contrast-induced Kidney InjuryFocus 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 03 mgdL in serum creatinine within 48 hours after contrast was accepted The definition of contrast nephropathy will be evaluated separately as both an increase of 05 mgdl or 25 increase in creatinine value compared to baseline and an increase of 03 mgdl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None