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RecruitingNCT06965764Updated May 14, 2025

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

An observational study in Contract Induced Nephropathy, sponsored by Sohag University. Recruiting at 2 sites in Egypt. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Contract Induced Nephropathy
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,220 studies on the registry; 629 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Title: Incidence of Contrast-Induced Nephropathy (CIN)

    increase in serum creatinine by ≥0.5 mg/dL or ≥25% from baseline. Serum creatinine will be measured before and 48-72 hours after contrast exposure.

    Time frame: Within 48-72 hours after contrast administration

Secondary outcomes

  1. Correlation between Risk Factors and Development of Contrast-Induced Nephropathy (CIN)

    This outcome assesses the correlation between the presence of risk factors - including age (in years), diabetes mellitus (yes/no), and baseline renal function \[estimated GFR in mL/min/1.73m², measured using the CKD-EPI equation\] - and the incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine by ≥0.5 mg/dL or ≥25% from baseline. CIN will be assessed within 48-72 hours after contrast administration. The correlation will be measured using multivariate logistic regression analysis or Spearman's correlation as appropriate.

    Time frame: At the time of enrollment and after 72 hours of contrast exposure

07

Study locations

2 of 2 sites recruiting
  • Sohag university hospitals
    Sohag, Egypt
    • Magdy A Amin, Professor · Contact
    Recruiting
  • Sohag university hospitals
    Sohag, Egypt
    • Magdy A Amin · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06965764
Lead sponsor
Sohag University
Responsible party
Esraa Ragab Youssef (Principal Investigator, Internal Medicine Resident, Sohag University) — Principal investigator
First posted
May 11, 2025
Start date
Mar 12, 2025
Primary completion
Sep 12, 2025 (estimated)
Completion
Sep 12, 2025 (estimated)
Last update
May 14, 2025

Study contacts

Esraa R Youssef, Resident
Contact
esraa_ragab_post@med.sohag.edu.eg
+201121932876
Usama A Arafa, professor
Contact
+201063064007

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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