Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Freiburg, Germany.
Trials. 2022 Mar 18;23(1):222. doi: 10.1186/s13063-022-06139-6.
Liver cirrhosis is a major healthcare problem and the mortality rate is high. During recent years, systemic inflammation has been recognized as a major driver of hepatic decompensation and progression of liver cirrhosis to acute-on-chronic liver failure (ACLF). The aim of the CYTOHEP study is to assess the impact of extracorporeal hemoadsorption with the CytoSorb adsorber on serum bilirubin concentrations, humoral inflammation parameters, liver function parameters, and patient survival in patients with ACLF and acute kidney injury (AKI).
The CYTOHEP study is a prospective, single-center, open-label, three-arm, randomized, controlled intervention trial. Patients with ACLF and AKI stage 3 according to Kidney Disease: Improving Global Outcome (KDIGO) criteria will be randomized into three groups to be treated with (1) continuous renal replacement therapy (CRRT) and CytoSorb, (2) CRRT without CytoSorb, and (3) without both, CRRT and CytoSorb. In the hemoadsorption group, CytoSorb will be used for 72 h. The other groups receive standard of care with early or late initiation of CRRT, respectively. Primary endpoint of the study is serum bilirubin concentration after 72 h, important secondary endpoints are 30-day survival and a panel of inflammatory parameters.
The CYTOHEP study is designed to evaluate the benefit of extracorporeal hemoadsorption in patients with ACLF. The results of this study will help to better understand the potential role of hemoadsorption for the treatment of ACLF and its impact on bilirubin levels, inflammatory parameters, and survival.
ClinicalTrials.gov NCT05019352. Registered on August 24, 2021. Deutsches Register Klinischer Studien (DRKS) DRKS00026082.
肝硬化是一个主要的医疗保健问题，死亡率很高。近年来，全身炎症已被认为是肝失代偿和肝硬化进展为慢加急性肝衰竭（ACLF）的主要驱动因素。CYTOHEP 研究的目的是评估体外血液吸附与 CytoSorb 吸附剂对 ACLF 和急性肾损伤（AKI）患者血清胆红素浓度、体液炎症参数、肝功能参数和患者生存的影响。
CYTOHEP 研究是一项前瞻性、单中心、开放标签、三臂、随机、对照干预试验。根据肾脏病：改善全球结局（KDIGO）标准，将 ACLF 和 AKI 期 3 的患者随机分为三组，分别接受（1）连续肾脏替代治疗（CRRT）和 CytoSorb、（2）无 CytoSorb 的 CRRT 和（3）无两者的 CRRT。在血液吸附组中，CytoSorb 将使用 72 小时。其他组分别接受标准治疗，早期或晚期开始 CRRT。研究的主要终点是 72 小时后血清胆红素浓度，重要的次要终点是 30 天生存率和一组炎症参数。
CYTOHEP 研究旨在评估体外血液吸附在 ACLF 患者中的益处。该研究的结果将有助于更好地了解血液吸附治疗 ACLF 的潜在作用及其对胆红素水平、炎症参数和生存率的影响。
ClinicalTrials.gov NCT05019352. 注册于 2021 年 8 月 24 日。德国临床试验注册中心（DRKS）DRKS00026082。
