Contrast-Associated Acute Kidney InjuryNCT07813819
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
An observational study of Contrast-Associated Acute Kidney Injury and Acute Kidney Injury, run by Assiut University.
Trial summary
Iodinated contrast dye used during computed tomography (CT) scans can sometimes cause kidney stress or damage, known as contrast-associated acute kidney injury (CA-AKI). Currently, doctors evaluate a patient's kidney safety using standard estimated glomerular filtration rate (eGFR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-Associated Acute Kidney Injury, Acute Kidney Injury, Contrast-Induced Nephropathy
- Type of treatment
- Injection or infusion
- How many people
- 1,112 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- 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
- All sexes
- Adult, Older adult
Study population: The study population consists of adult outpatients (aged >= 18 years) referred to the Department of Clinical Radiology at Assiut University Hospitals, a tertiary healthcare center in Assiut, Egypt, for clinically indicated intravenous contrast-enhanced computed tomography (CE-CT). Eligible participants have documented baseline serum creatinine and eGFR measured within 48 hours prior to contrast exposure. The population excludes patients with end-stage renal disease (CKD stage 5 or chronic dialysis), intravascular iodinated contrast exposure within the preceding 7 days, acute hemodynamic instability, and pregnant or lactating females.
Who may be able to join
- Adult patients aged 18 years or older referred for clinically indicated outpatient intravenous contrast-enhanced computed tomography (CE-CT) scan.
- Documented baseline serum creatinine and estimated glomerular filtration rate (eGFR) measured within 48 hours prior to contrast exposure.
- Provision of written informed consent prior to study enrollment.
Who cannot join
- Severe chronic kidney disease (CKD stage 5, baseline eGFR < 15 mL/min/1.73 m2) or currently on chronic renal replacement therapy (hemodialysis or peritoneal dialysis).
- Exposure to intravascular iodinated contrast media within the preceding 7 days.
- Hemodynamic instability, acute decompensated heart failure, or cardiogenic shock upon presentation.
- Pregnant or lactating females.
- Inability or unwillingness to comply with the 48 to 72-hour follow-up serum creatinine testing.
About this study
Official title: Prospective Evaluation of Contrast Volume as a Predictor of Contrast-Associated Acute Kidney Injury Following Intravenous Contrast-Enhanced Computed Tomography
Iodinated contrast dye used during computed tomography (CT) scans can sometimes cause kidney stress or damage, known as contrast-associated acute kidney injury (CA-AKI). Currently, doctors evaluate a patient's kidney safety using standard estimated glomerular filtration rate (eGFR). However, standard eGFR is calculated for an average body size rather than an individual's actual body size, which can misrepresent a person's true kidney excretion capacity. This study aims to evaluate whether comparing the volume of contrast dye directly to a patient's true, individualized kidney function (the contrast volume-to-absolute GFR ratio) can accurately predict the risk of developing kidney injury after an intravenous contrast-enhanced CT scan.
This is a prospective, observational study involving adult outpatients who are already scheduled for a clinically necessary contrast-enhanced CT scan. Participation is observational and does not alter the patient's planned scan, medical treatment, or the amount of contrast dye administered by their healthcare team.
Read more
Participants will:
- Have their baseline kidney function assessed through a routine blood test (serum creatinine) within 48 hours prior to their CT scan.
- Have their height and weight recorded to calculate their individualized, absolute kidney function.
- Complete a follow-up blood test (serum creatinine) 48 to 72 hours after the CT scan to evaluate any changes in kidney function.
Researchers will analyze whether the ratio of contrast volume to absolute kidney function reliably identifies patients at higher risk of contrast-associated kidney complications, helping to establish safer, personalized contrast dosing strategies in the future.
- Conditions
- Contrast-Associated Acute Kidney Injury, Acute Kidney Injury, Contrast-Induced Nephropathy, Acute Renal Failure
- Keywords
- Contrast Media, Contrast-Enhanced Computed Tomography, Absolute GFR, Contrast Volume-to-GFR Ratio, Nephrotoxicity, KDIGO, Iopromide, Iodixanol
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-Enhanced CT Cohort | Adult outpatient participants (aged ≥ 18 years) undergoing clinically indicated intravenous contrast-enhanced computed tomography (CE-CT). Participants receive standard-of-care intravenous iodinated contrast media (low-osmolar Iopromide [300 or 370 mg I/mL] or iso-osmolar Iodixanol [320 mg I/mL]) administered via an automated power injector. Baseline renal function (serum creatinine and eGFR) is assessed within 48 hours prior to scan, with renal excretion capacity determined as absolute GFR de-indexed to body surface area using the DuBois formula. Participants undergo follow-up serum creatinine testing at 48 to 72 hours post-contrast exposure to evaluate the incidence of contrast-associated acute kidney injury (CA-AKI) relative to contrast volume and the dynamic contrast volume-to-absolute GFR (CV/GFR_abs) ratio. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Contrast-Associated Acute Kidney Injury (CA-AKI)
Contrast-associated acute kidney injury (CA-AKI) is defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an absolute increase in serum creatinine of >= 0.3 mg/dL (>= 26.5 umol/L) within 48 hours, or a relative increase of >= 1.5 times the baseline value. Baseline serum creatinine is collected within 48 hours prior to contrast exposure, and follow-up serum creatinine is measured between 48 and 72 hours following intravenous contrast-enhanced CT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-Associated Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansour Saleh Hamed Amar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813819
- Sponsor's protocol ID
- Contrast Volume & CA-AKI in CT
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Contrast Volume as a Predictor of Contrast-Associated Acute Kidney Injury Following Intravenous Contrast-Enhanced Computed Tomography
- ClinicalTrials.gov ID
- NCT07813819
- Acronym / sponsor ID
- Contrast Volume & CA-AKI in CT
- Conditions
- Contrast-Associated Acute Kidney Injury, Acute Kidney Injury, Contrast-Induced Nephropathy, Acute Renal Failure
- Keywords
- Contrast Media, Contrast-Enhanced Computed Tomography, Absolute GFR, Contrast Volume-to-GFR Ratio, Nephrotoxicity, KDIGO, Iopromide, Iodixanol
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,112 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Sep 2026 (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.
Iodinated contrast dye used during computed tomography (CT) scans can sometimes cause kidney stress or damage, known as contrast-associated acute kidney injury (CA-AKI). Currently, doctors evaluate a patient's kidney safety using standard estimated glomerular filtration rate (eGFR). However, standard eGFR is calculated for an average body size rather than an individual's actual body size, which can misrepresent a person's true kidney excretion capacity. This study aims to evaluate whether comparing the volume of contrast dye directly to a patient's true, individualized kidney function (the contrast volume-to-absolute GFR ratio) can accurately predict the risk of developing kidney injury after an intravenous contrast-enhanced CT scan.
This is a prospective, observational study involving adult outpatients who are already scheduled for a clinically necessary contrast-enhanced CT scan. Participation is observational and does not alter the patient's planned scan, medical treatment, or the amount of contrast dye administered by their healthcare team.
Participants will:
- Have their baseline kidney function assessed through a routine blood test (serum creatinine) within 48 hours prior to their CT scan.
- Have their height and weight recorded to calculate their individualized, absolute kidney function.
- Complete a follow-up blood test (serum creatinine) 48 to 72 hours after the CT scan to evaluate any changes in kidney function.
Researchers will analyze whether the ratio of contrast volume to absolute kidney function reliably identifies patients at higher risk of contrast-associated kidney complications, helping to establish safer, personalized contrast dosing strategies in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-Enhanced CT Cohort | – | –Adult outpatient participants (aged ≥ 18 years) undergoing clinically indicated intravenous contrast-enhanced computed tomography (CE-CT). Participants receive standard-of-care intravenous iodinated contrast media (low-osmolar Iopromide [300 or 370 mg I/mL] or iso-osmolar Iodixanol [320 mg I/mL]) administered via an automated power injector. Baseline renal function (serum creatinine and eGFR) is assessed within 48 hours prior to scan, with renal excretion capacity determined as absolute GFR de-indexed to body surface area using the DuBois formula. Participants undergo follow-up serum creatinine testing at 48 to 72 hours post-contrast exposure to evaluate the incidence of contrast-associated acute kidney injury (CA-AKI) relative to contrast volume and the dynamic contrast volume-to-absolute GFR (CV/GFR_abs) ratio. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult outpatients (aged >= 18 years) referred to the Department of Clinical Radiology at Assiut University Hospitals, a tertiary healthcare center in Assiut, Egypt, for clinically indicated intravenous contrast-enhanced computed tomography (CE-CT). Eligible participants have documented baseline serum creatinine and eGFR measured within 48 hours prior to contrast exposure. The population excludes patients with end-stage renal disease (CKD stage 5 or chronic dialysis), intravascular iodinated contrast exposure within the preceding 7 days, acute hemodynamic instability, and pregnant or lactating females.
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or older referred for clinically indicated outpatient intravenous contrast-enhanced computed tomography (CE-CT) scan.
- Documented baseline serum creatinine and estimated glomerular filtration rate (eGFR) measured within 48 hours prior to contrast exposure.
- Provision of written informed consent prior to study enrollment.
Key exclusion criteria (5 listed)
- Severe chronic kidney disease (CKD stage 5, baseline eGFR < 15 mL/min/1.73 m2) or currently on chronic renal replacement therapy (hemodialysis or peritoneal dialysis).
- Exposure to intravascular iodinated contrast media within the preceding 7 days.
- Hemodynamic instability, acute decompensated heart failure, or cardiogenic shock upon presentation.
- Pregnant or lactating females.
- Inability or unwillingness to comply with the 48 to 72-hour follow-up serum creatinine testing.
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
Number of Participants With Contrast-Associated Acute Kidney Injury (CA-AKI)
Time frame: Baseline
Contrast-associated acute kidney injury (CA-AKI) is defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an absolute increase in serum creatinine of >= 0.3 mg/dL (>= 26.5 umol/L) within 48 hours, or a relative increase of >= 1.5 times the baseline value. Baseline serum creatinine is collected within 48 hours prior to contrast exposure, and follow-up serum creatinine is measured between 48 and 72 hours following intravenous contrast-enhanced CT.
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 10 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast-Associated Acute Kidney Injury and Acute Kidney Injury, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Contrast-Associated Acute Kidney Injury (CA-AKI) (time frame: Baseline). 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 10 Sep 2026.