Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
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.
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants With Contrast-Associated Acute Kidney Injury (CA-AKI)
Časové okno: Baseline
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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.
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Baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Contrast Volume & CA-AKI in CT
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