BACKGROUND Predicting the risk of AKI-CKD transition remains a major challenge in management of acute decompensated heart failure and AKI. This study investigated the clinical utility of urinary cytokeratin 20 (CK20), a novel biomarker reflecting severity of histological acute tubular injury, for identifying patients at risk of AKI-CKD progression. METHODS This prospective cohort study included a Test set comprising 279 consecutive hospitalized patients with acute decompensated heart failure and AKI in 5 centers and a Validation set enrolling 206 similar patients at an external center. Urinary CK20 and seven reported renal tubular injury biomarkers at the time of AKI diagnosis were measured. The primary outcome was a composite of AKI-CKD transition 90 days after AKI or all-cause death within 90 days. The secondary outcome was AKI-CKD progression 90 days after AKI. RESULTS In the Test set, 115 (41%) patients reached the primary endpoint. Concentrations of urinary CK20 peaked on the day of AKI diagnosis and remained elevated 14 days after AKI. After multivariable adjustment, the highest tertile of urinary CK20 was associated with 21-fold higher risk of the primary outcome and 29-fold higher risk of the secondary outcome. For predicting the primary and the secondary outcomes, urinary CK20 at the time of AKI diagnosis had area under the receiver-operating characteristic curves (AUC) of 0.82 (95% confidence interval [CI], 0.77-0.87) and 0.81 (95% CI, 0.75-0.87), and outperformed other reported biomarkers reflecting acute tubular injury and the risk of CKD. Adding urinary CK20 to the clinical variables improved the ability for predicting the primary outcome with an AUC of 0.90 (95% CI, 0.85-0.94), and largely improved the risk reclassification. The ability of urinary CK20 in predicting AKI-CKD transition was further confirmed in the Validation set. CONCLUSIONS Urinary CK20 improved prediction of the risk for transition from AKI to CKD in patients with acute decompensated heart failure and AKI.

中文翻译：

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尿细胞角蛋白 20 作为急性失代偿性心力衰竭和急性肾损伤患者 AKI-CKD 转变的生物标志物。


背景 预测 AKI-CKD 转变的风险仍然是急性失代偿性心力衰竭和 AKI 管理的主要挑战。本研究调查了尿细胞角蛋白 20 （CK20） 的临床效用，CK20 是一种反映组织学急性肾小管损伤严重程度的新型生物标志物，用于识别有 AKI-CKD 进展风险的患者。方法 这项前瞻性队列研究包括一个测试集，包括 5 个中心的 279 名连续住院的急性失代偿性心力衰竭和 AKI 患者，以及一个验证集，在外部中心招募了 206 名类似患者。测量 AKI 诊断时尿 CK20 和 7 例报告的肾小管损伤生物标志物。主要结局是 AKI 后 90 天 AKI-CKD 过渡或 90 天内全因死亡的复合结局。次要结局是 AKI 后 90 天的 AKI-CKD 进展。结果 在测试集中，115 例 （41%） 患者达到主要终点。尿 CK20 浓度在 AKI 诊断当天达到峰值，并在 AKI 后 14 天保持升高。多变量调整后，尿 CK20 的最高三分位数与主要结局风险高 21 倍和次要结局风险高 29 倍相关。在预测主要和次要结局方面，AKI 诊断时尿 CK20 的受试者工作特征曲线下面积 （AUC） 为 0.82 （95% 置信区间 [CI]，0.77-0.87） 和 0.81 （95% CI，0.75-0.87），优于其他报告的反映急性肾小管损伤和 CKD 风险的生物标志物。将尿液 CK20 添加到临床变量中提高了预测主要结局的能力，AUC 为 0.90 （95% CI，0.85-0.94），并大大改善了风险再分类。 尿液 CK20 预测 AKI-CKD 转变的能力在验证集中得到进一步证实。结论 尿 CK20 改善了急性失代偿性心力衰竭和 AKI 患者从 AKI 转变为 CKD 风险的预测。