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Prospective evaluation of contrast volume as a predictor of Contrast-Associated acute kidney injury following intravenous Contrast-Enhanced computed tomography

NCT ID NCT07813819

NEW Sponsor: Assiut University Source: ClinicalTrials.gov ↗

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

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). 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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,112 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Acute renal failure Contrast-associated acute kidney injury Contrast-induced nephropathy

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