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

6. september 2026 opdateret af: Mansour Saleh Hamed Amar, Assiut University

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1112

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Contrast-Associated Acute Kidney Injury (CA-AKI)
Tidsramme: 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.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. november 2027

Datoer for studieregistrering

Først indsendt

6. september 2026

Først indsendt, der opfyldte QC-kriterier

6. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2026

Sidst verificeret

1. september 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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