Study of Contrast - Induced Nephropathy After Intravenous Contrast Procedures at Sohag University Hospitals

NCT ID: NCT06965764

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-09-12

Brief Summary

Contrast-induced nephropathy (CIN) is a serious complication of angiographic procedures and results from administration of iodinated contrast media (CM).

CIN is the third most common cause of hospital acquired acute renal injury representing about 12% of the cases. The reported incidence of CIN varies widely across the literature, depending on the patient population studied and the baseline risk factors . An overall incidence of CIN following intraarterial contrast injection in the general population was reported to be 0.6-2.3%.

Although the incidence of CIN is low in patients with normal renal function, its prevalence can be much higher in several patient subsets e.g. diabetics, patients with existing renal insufficiency.

Contrast-induced nephropathy is defined as a rise in serum creatinine of at least 0.5 mg/dL or a 25% increase from baseline within 48 to 72 hours after contrast exposure. The Kidney Disease Improving Global Outcome (KDIGO) definition is different, with stage 1 being a rapid rise of creatinine to greater than 0.3 mg/dL within 48 hours or the relative rise of 50% or more from baseline in 7 days or less or a reduction in urine output to less than 0.5 ml/kg/hr for 6 to 12 hours. This severity is further staged based on creatinine levels, urine output, or the need for renal replacement therapy.

In most cases of CIN there is an asymptomatic, non-oliguric rise of serum creatinine within 24hours; however, in more severe cases, the creatinine concentration may not peak until 5-10 days and the increase may be associated with oliguria, It may occasionally progress to end-stage renal failure.

The incidence of CIN varies widely among the publications in the literature and studies. In this study, we will evaluate the incidence of CIN amongst patients receiving intravenous contrast in sohag university hospital, to study the variations in serum creatinine levels with contrast administration.

Conditions

Contract Induced Nephropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1- Inpatients and outpatients aged 18years and above who underwent single intravenous Contrast procedures.

Exclusion Criteria

1. Patients below 18 years, failure to obtain consent.

2. Patients with ESRD/ on maintenance hemodialysis.

3. New-York Heart Association class IV Congestive Cardiac Failure (CCF) or patients with cardiogenic shock .

4. History of hypersensitivity to contrast in the past or exposure to contrast in the last 24-48 hours, 5-nursing/pregnant subjects.

5. Patients with malignancy or other organ failure like decompensated liver cirrhosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Ragab Youssef

Principal Investigator, Internal Medicine Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university hospitals

Sohag, , Egypt

Site Status: RECRUITING

Sohag university hospitals

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Esraa R Youssef, Resident

Role: CONTACT

esraa_ragab_post@med.sohag.edu.eg

+201121932876

Usama A Arafa, professor

Role: CONTACT

+201063064007

Facility Contacts

Magdy A Amin, Professor

Role: primary

Magdy A Amin

Role: primary

Other Identifiers

Soh-Med--25-3-03MS

Identifier Type: -

Identifier Source: org_study_id