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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06965764
Enrollment
200
Registered
2025-05-11
Start date
2025-03-12
Completion date
2025-09-12
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contract Induced Nephropathy

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.

Interventions

None listed

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Title: Incidence of Contrast-Induced Nephropathy (CIN)Within 48-72 hours after contrast administrationincrease 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.

Secondary

MeasureTime frameDescription
Correlation between Risk Factors and Development of Contrast-Induced Nephropathy (CIN)At the time of enrollment and after 72 hours of contrast exposureThis 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.

Countries

Egypt

Contacts

Primary ContactEsraa R Youssef, Resident
esraa_ragab_post@med.sohag.edu.eg+201121932876
Backup ContactUsama A Arafa, professor
+201063064007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026