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.
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.
Usama A Arafa, professor contact
Egypt2 sites, 2 recruiting
- Recruiting
Sohag university hospitals
Sohag
Magdy A Amin, Professor
- Recruiting
Sohag university hospitals
Sohag
Magdy A Amin
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.
- Conditions
- Contract Induced Nephropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted11 May 2025
- Study start12 Mar 2025
- Primary completion12 Sep 2025 (estimated)
- Study completion12 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contract Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ragab Youssef, Sohag University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Contrast - Induced Nephropathy After Intravenous Contrast Procedures at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06965764
- Acronym / sponsor ID
- Soh-Med--25-3-03MS
- Conditions
- Contract Induced Nephropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 12 Sep 2025 (estimated)
- Study completion
- 12 Sep 2025 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients aged 18years and above who underwent single intravenous Contrast procedures
Key inclusion criteria (1 listed)
- 1- Inpatients and outpatients aged 18years and above who underwent single intravenous Contrast procedures.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Title: Incidence of Contrast-Induced Nephropathy (CIN)
Time frame: Within 48-72 hours after contrast administration
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.
1 secondary outcome
Correlation between Risk Factors and Development of Contrast-Induced Nephropathy (CIN)
Time frame: At the time of enrollment and after 72 hours of contrast exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Usama A Arafa, professor contact
2 sites in 1 country: see every site and its status.
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.