Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin, Hamburg, Deutschland.
Universitätsklinikum Münster, Medizinische Klinik B für Gastroenterologie and Hepatologie, Münster.
Medicine (Baltimore). 2021 Feb 19;100(7):e24653. doi: 10.1097/MD.0000000000024653.
The objective of this registry is to collect data on real-life treatment conditions for patients for whom multiple organ dialysis with Advanced Organ Support (ADVOS) albumin hemodialysis is indicated.This registry was performed under routine conditions and without any study-specific intervention, diagnostic procedures, or assessments. Data on clinical laboratory tests, health status, liver function, vital signs, and examinations were collected (DRKS-ID: DRKS00017068). Mortality rates 28 and 90 days after the first ADVOS treatment, adverse events and ADVOS treatment parameters, including treatment abortions, were documented.This analysis was performed 2 years after the first patient was included on January 18, 2017. As of February 20, 2019, 4 clinical sites in Germany participated and enrolled 118 patients with a median age of 60 (IQR: 45, 69) of whom 70 were male (59.3%). Patients had a median SOFA Score of 14 (IQR: 11, 16) and a predicted mortality of 80%. The median number of failing organs was 3 (IQR: 2, 4).Four hundred twenty nine ADVOS treatments sessions were performed with a median duration of 17 hours (IQR: 6, 23). A 5.8% of the ADVOS sessions (25 of 429) were aborted due to device related errors, while 14.5% (62 of 429) were stopped for other reasons. Seventy nine adverse events were documented, 13 of them device related (all clotting, and all recovered without sequels).A significant reduction in serum creatinine (1.5 vs 1.2 mg/dl), blood urea nitrogen (24 vs 17 mg/dl) and bilirubin (6.9 vs 6.5 mg/dl) was observed following the first ADVOS treatment session. Blood pH, bicarbonate (HCO3-) and base excess returned to the physiological range, while partial pressure of carbon dioxide (pCO2) remained unchanged. At the time of the analysis, 28- and 90-day mortality were 60% and 65%, respectively, compared to an expected ICU-mortality rate of 80%. SOFA score was an independent predictor for outcome in a multivariable logistic regression analysis.The reported data show a high quality and completion of all participating centers. Data interpretation must be cautious due to the small number of patients, and the nature of the registry, without a control group. However, the data presented here show an improvement of expected mortality rates. Minor clotting events similar to other dialysis therapies occurred during the treatments.
本注册研究旨在收集 ADVOS 白蛋白血液透析适应证患者的真实治疗数据。该注册研究是在常规条件下进行的，没有任何特定于研究的干预、诊断程序或评估。收集了临床实验室检查、健康状况、肝功能、生命体征和检查的数据（DRKS-ID：DRKS00017068）。记录了首次 ADVOS 治疗后 28 天和 90 天的死亡率、不良事件以及 ADVOS 治疗参数，包括治疗中止。该分析是在 2017 年 1 月 18 日首次入组患者后 2 年进行的。截至 2019 年 2 月 20 日，德国的 4 个临床中心参与并纳入了 118 名中位年龄为 60（IQR：45，69）岁的患者，其中 70 名男性（59.3%）。患者的 SOFA 评分中位数为 14（IQR：11，16），预计死亡率为 80%。中位衰竭器官数为 3（IQR：2，4）。共进行了 429 次 ADVOS 治疗，治疗时间中位数为 17 小时（IQR：6，23）。由于设备相关问题，5.8%（25/429）的 ADVOS 治疗被中止，而 14.5%（62/429）因其他原因停止。记录了 79 例不良事件，其中 13 例与设备相关（均为凝血，均无后遗症恢复）。首次 ADVOS 治疗后，血清肌酐（1.5 与 1.2mg/dl）、血尿素氮（24 与 17mg/dl）和胆红素（6.9 与 6.5mg/dl）显著降低。血液 pH 值、碳酸氢盐（HCO3-）和碱剩余恢复到生理范围，而二氧化碳分压（pCO2）保持不变。在分析时，28 天和 90 天的死亡率分别为 60%和 65%，而 ICU 死亡率预计为 80%。多变量逻辑回归分析显示 SOFA 评分是结局的独立预测因素。本报告数据显示所有参与中心的高质量和完整性。由于患者数量少，以及注册研究的性质，没有对照组，因此必须谨慎解释数据。然而，这里提供的数据显示，预期死亡率有所改善。在治疗过程中发生了类似于其他透析治疗的轻微凝血事件。
