## Protocol Section
### Identification Module
**NCT ID:** NCT06418542

**Brief Title:** Contrast Nephropathy Associated FFA

**Official Title:** Assessment of the Frequency of Fundus Fluorescein Angiography Relationship With Contrast Nephropathy and Associated Factors

#### Organization Study ID Info
**ID:** E-48865165
#### Organization
**Class:** OTHER
**Full Name:** Saglik Bilimleri Universitesi
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Saglik Bilimleri Universitesi

#### Responsible Party

**Investigator Affiliation:** Saglik Bilimleri Universitesi

**Investigator Full Name:** NUR SENA ÇOBAN

**Investigator Title:** Assistant Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Contrast-induced Nephropathy

- Acute Kidney Injury

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients who have chronic renal disease

**Intervention Names:**

- Device: use of florescein

**Label:** END

**Type:** OTHER

#### Arm Group 2

**Description:** patients who don't have chronic renal disease

**Intervention Names:**

- Device: use of florescein

**Label:** END free

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- END

- END free

**Description:** Fluorescein, an organic contrast agent, is used in FFA to detect retinal pathologies.

**Name:** use of florescein

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Contrast Nephropathy associated FFA

**Time Frame:** 48-72 hours

### Eligibility Module

**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

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Saglik Bilimleri University

**Zip:** 34000

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Nephropathy

- ID: M28998

- Name: Acute Kidney Injury

- Relevance: HIGH

- As Found: Acute Kidney Injury

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058186

- Term: Acute Kidney Injury

- ID: D000007674

- Term: Kidney Diseases

### Misc Info Module

- Version Holder: 2024-05-31
