Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT

NCT07813819 | Not Yet Recruiting

• 1 other identifier: Contrast Volume & CA-AKI in CT
• Study Type: observational
• Target: 1,112
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Internal Medicine

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09