Biomarker−dependent detection of contrast−associated acute kidney injury after intra−arterial contrast procedures: an exploratory randomized trial
- 1Hospital Geral de Goiânia Dr. Alberto Rassi (HGG), Goiânia, Brazil
- 2São Paulo State University (UNESP), Botucatu, Brazil
Abstract
Background: Contrast-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.
Methods: This 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.
Results: Substantial 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.
Conclusions: CA-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 registration: Brazilian Registry of Clinical Trials (ReBEC), RBR3h2gv8r (Universal Trial Number U1111-1277-3145), registered on 31 March 2023 retrospectively registered.
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BibTeX
@article{fernandes2026biomarkerdependent,
title = {{Biomarker−dependent detection of contrast−associated acute kidney injury after intra−arterial contrast procedures: an exploratory randomized trial}},
author = {Daniel Cesar Magalhaes Fernandes and Roberto Gomide and Thais Rodrigues Magalhaes and Rosa Tanmyris de Sousa Lima and Romulo Mendes Silva and Paulo Ricardo Alves Moreira and Alef Ribeiro Souza and Delvo Vasquez Netto and Maria Luiza Amaral and Lorrayne Silva Pequeno and Matheus Bertanha and Marcone Lima Sobreira},
journal = {BMC Nephrology},
year = {2026},
month = sep,
doi = {10.1186/s12882-026-05342-w},
url = {https://doi.org/10.1186/s12882-026-05342-w},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Biomarker−dependent detection of contrast−associated acute kidney injury after intra−arterial contrast procedures: an exploratory randomized trial
AU - Daniel Cesar Magalhaes Fernandes
AU - Roberto Gomide
AU - Thais Rodrigues Magalhaes
AU - Rosa Tanmyris de Sousa Lima
AU - Romulo Mendes Silva
AU - Paulo Ricardo Alves Moreira
AU - Alef Ribeiro Souza
AU - Delvo Vasquez Netto
AU - Maria Luiza Amaral
AU - Lorrayne Silva Pequeno
AU - Matheus Bertanha
AU - Marcone Lima Sobreira
PY - 2026
DA - 2026/09/24
JO - BMC Nephrology
DO - 10.1186/s12882-026-05342-w
UR - https://doi.org/10.1186/s12882-026-05342-w
AB - Background: Contrast-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. Methods: This 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. Results: Substantial 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. Conclusions: CA-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 registration: Brazilian Registry of Clinical Trials (ReBEC), RBR3h2gv8r (Universal Trial Number U1111-1277-3145), registered on 31 March 2023 retrospectively registered.
SN - 1471-2369
ER -