Shi Keran, Jiang Wei, Song Lin, Li Xianghui, Wang Jing, Zhao Renyan, Wang Haixia, Sun Fan, Wang Ran, Pu Cenlu, Zhang Chuanqing, Li Luanluan, Feng Yunfan, Yu Jiangquan, Zheng Ruiqiang
Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou, 225001, China.
Trials. 2025 Aug 26;26(1):312. doi: 10.1186/s13063-025-09058-4.
Sepsis-associated acute kidney injury (SA-AKI) is a commonly encountered complex heterogeneous syndrome in critically ill patients with sepsis. Under the interaction of genotype and pathogenic factors, SA-AKI can lead to various clinical phenotypes and subphenotypes, and this heterogeneity complicates the assessment of the efficacy of treatment measures for sepsis in clinical trials. Early identification of SA-AKI high-risk patients with specific subphenotypes and timely implementation of supportive treatments may improve adverse outcomes for these patients. High levels of C-C motif chemokine ligand 14 (CCL14) serve as a biomarker that can early identify critically ill patients with persistent SA-AKI. However, the effects of different supportive treatment strategies on the prognosis of SA-AKI patients identified by CCL14 remain unclear. We hypothesize that integrated blood purification (HBP) therapy has a beneficial effect in the treatment of SA-AKI identified by CCL14.
This is a single-center, blinded, randomized controlled trial. After the patients were admitted to the ICU, blood and urine samples were taken, and the urine CCL14 concentration was measured. Subsequently, they were randomly assigned to the continuous veno-venous hemofiltration (CVVH) group and the hybrid blood purification (HBP) group. The HBP group received blood hemoperfusion (HP) treatment using the HA380 hemoperfusion filter (Jafron, China) and CVVH treatment using the AN69 ST100 blood filter (Baxter, USA). The CVVH group used only the AN69 ST100 blood filter (Baxter, USA) and selected the CVVH mode for continuous renal replacement therapy (CRRT). The primary outcome was the all-cause mortality rate at 30 days after enrollment. The secondary outcomes included the all-cause mortality rate at 90 days, the incidence of chronic kidney disease (CKD) within 90 days, changes in kidney function 72 h after enrollment, variations in endotoxin levels, changes in coagulation function parameters, alterations in inflammatory factor levels, changes in plasma endothelial barrier-related indicators, variations in hemodynamic parameters, changes in SOFA (Sequential (Sepsis-related) Organ Failure Assessment) score, changes in Apache II score, duration of kidney replacement therapy (KRT) during hospitalization, duration of mechanical ventilation, duration of stay in ICU, and duration of stay in hospital.
This study aims to explore the impact of the HBP therapy on the 30-day all-cause mortality rate of patients with SA-AKI subtypes recognized by CCL14, providing relatively reliable research evidence for determining the optimal treatment approach for patients with persistent severe SA-AKI in clinical practice.
Chinese Clinical Trial Registry (CHICTR), ChiCTR2400093572. Registered on 9 December 2024, https://www.chictr.org.cn/showproj.html?proj=241688.
脓毒症相关急性肾损伤(SA-AKI)是脓毒症重症患者中常见的复杂异质性综合征。在基因型和致病因素的相互作用下,SA-AKI可导致多种临床表型和亚表型,这种异质性使临床试验中脓毒症治疗措施疗效的评估变得复杂。早期识别具有特定亚表型的SA-AKI高危患者并及时实施支持治疗可能改善这些患者的不良预后。高水平的C-C基序趋化因子配体14(CCL14)作为一种生物标志物,可早期识别持续性SA-AKI的重症患者。然而,不同的支持治疗策略对经CCL14识别的SA-AKI患者预后的影响仍不明确。我们假设集成血液净化(HBP)疗法对经CCL14识别的SA-AKI治疗有益。
这是一项单中心、盲法、随机对照试验。患者入住重症监护病房(ICU)后,采集血液和尿液样本,测量尿CCL14浓度。随后,将他们随机分为持续静脉-静脉血液滤过(CVVH)组和混合血液净化(HBP)组。HBP组使用HA380血液灌流器(中国健帆)进行血液灌流(HP)治疗,并使用AN69 ST100血液滤器(美国百特)进行CVVH治疗。CVVH组仅使用AN69 ST100血液滤器(美国百特),并选择CVVH模式进行连续性肾脏替代治疗(CRRT)。主要结局是入组后30天的全因死亡率。次要结局包括90天的全因死亡率、90天内慢性肾脏病(CKD)的发生率、入组后72小时肾功能的变化、内毒素水平的变化、凝血功能参数的变化、炎症因子水平的变化、血浆内皮屏障相关指标的变化、血流动力学参数的变化、序贯器官衰竭评估(SOFA)评分的变化、急性生理和慢性健康状况评分系统(Apache II)评分的变化、住院期间肾脏替代治疗(KRT)的持续时间机械通气的持续时间、在ICU的住院时间和住院时间。
本研究旨在探讨HBP疗法对经CCL14识别的SA-AKI亚型患者30天全因死亡率的影响,为临床实践中确定持续性重症SA-AKI患者的最佳治疗方法提供相对可靠的研究证据。
中国临床试验注册中心(CHICTR),ChiCTR2400093572。于2024年12月9日注册,https://www.chictr.org.cn/showproj.html?proj=241688。