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Contract Induced NephropathyNCT06965764

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

An observational study of Contract Induced Nephropathy, run by Sohag University at 2 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Contract Induced Nephropathy
How many people
200 participants
Where
2 sitesEgypt
Study dates
12 Mar 2025to 12 Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients below 18 years, failure to obtain consent.
  • Patients with ESRD/ on maintenance hemodialysis.
  • New-York Heart Association class IV Congestive Cardiac Failure (CCF) or patients with cardiogenic shock .
  • History of hypersensitivity to contrast in the past or exposure to contrast in the last 24-48 hours, 5-nursing/pregnant subjects.
  • Patients with malignancy or other organ failure like decompensated liver cirrhosis

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Esraa R Youssef, Resident contact

+201121932876

esraa_ragab_post@med.sohag.edu.eg

Usama A Arafa, professor contact

+201063064007

Egypt2 sites, 2 recruiting
  • Sohag university hospitals

    Sohag

    Magdy A Amin, Professor

    Recruiting
  • Sohag university hospitals

    Sohag

    Magdy A Amin

    Recruiting

Other trials in Egypt

About this study

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%.

Read more

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 48-72 hours after contrast administration

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start12 Mar 2025
  3. Primary completion12 Sep 2025 (estimated)
  4. Study completion12 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965764
Sponsor's protocol ID
Soh-Med--25-3-03MS
Status last verified
Mar 2025
First submitted
16 Apr 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Contract Induced Nephropathy, run by Sohag University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esraa R Youssef, Resident (+201121932876, esraa_ragab_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Title: Incidence of Contrast-Induced Nephropathy (CIN) (time frame: Within 48-72 hours after contrast administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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