Trial reportBMC nephrology2026
Biomarker-dependent detection of contrast-associated acute kidney injury after intra-arterial contrast procedures: an exploratory randomized trial.
Trial report in BMC nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
backgroundContrast-associated acute kidney injury (CA-AKI) remains a controversial clinical entity, partly because incidence estimates vary according to the diagnostic criteria and biomarkers used. Serum creatinine-based definitions may underestimate early functional renal impairment after contrast exposure, whereas cystatin C has emerged as a more sensitive early biomarker of glomerular filtration changes. This study aimed to evaluate how biomarker selection influences CA-AKI detection and interpretation of preventive strategies after intra-arterial contrast procedures.
methodsThis prospective, randomized, single-blind exploratory trial included 76 patients with peripheral arterial disease undergoing elective intra-arterial contrast-enhanced vascular procedures, most of which were diagnostic angiographic examinations. Participants were stratified according to baseline renal function and randomized to receive either standardized hydration alone or hydration plus high-dose atorvastatin and N-acetylcysteine. CA-AKI was assessed using two predefined definitions: historical creatinine-based criteria (≥ 25% or ≥ 0.5 mg/dL increase within 72 h) and cystatin C-based criteria (≥ 10% increase within 24 h). Diagnostic concordance and biomarker-dependent differences in event ascertainment were evaluated.
resultsSubstantial diagnostic discordance was observed between creatinine- and cystatin C-defined CA-AKI, with no overlapping cases and poor agreement between biomarkers (κ = 0.07). Creatinine-based criteria identified 4 CA-AKI events, whereas cystatin C identified 7 additional early functional injury cases. Biomarker-dependent differences in event detection varied across renal function strata, particularly among patients with preserved baseline renal function. Low event rates using creatinine-based criteria limited definitive assessment of preventive efficacy. Exploratory analyses suggested that biomarker selection influenced the apparent magnitude and direction of treatment-effect estimates.
conclusionsCA-AKI ascertainment after intra-arterial contrast exposure is strongly biomarker-dependent. Historical creatinine-based definitions may underestimate early functional renal impairment and influence interpretation of preventive strategies. These findings highlight the importance of endpoint selection in CA-AKI clinical trials and support further investigation of sensitive functional biomarkers in larger prospective studies.
trial registrationBrazilian Registry of Clinical Trials (ReBEC), RBR3h2gv8r (Universal Trial Number U1111-1277-3145), registered on 31 March 2023 retrospectively registered.
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