Clinical trial NCT06965764: Study of Contrast - Induced Nephropathy After Intravenous Contrast Procedures at Sohag University Hospitals
Official title: Study of Contrast - Induced Nephropathy After Intravenous Contrast Procedures at Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Contract Induced Nephropathy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients and outpatients aged 18years and above who underwent single intravenous Contrast procedures

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.


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

Primary outcomes:
measure: Title: Incidence of Contrast-Induced Nephropathy (CIN)
timeFrame: Within 48-72 hours after contrast administration
Secondary outcomes:
measure: Correlation between Risk Factors and Development of Contrast-Induced Nephropathy (CIN)
timeFrame: At the time of enrollment and after 72 hours of contrast exposure
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospitals
city: Sohag
country: Egypt
facility: Sohag university hospitals
Study officials:
References: