Department of Hepatology and GastroenterologyAarhus University HospitalAarhus NDenmark.
Department of Clinical MedicineAarhus UniversityAarhusDenmark.
Hepatol Commun. 2022 Nov;6(11):3175-3185. doi: 10.1002/hep4.2065. Epub 2022 Aug 16.
Ascites formation is a sign of decompensation of cirrhosis and heralds a poor prognosis. The widely used standard binary classification of ascites as diuretic-responsive or refractory does not cover the spectrum of ascites and has limited prognostic information. We developed the Cirrhotic Ascites Severity (CIRAS) model to predict 1-year mortality among 465 patients randomized to placebo in the satavaptan trials investigating treatment of cirrhotic ascites. We used multivariable logistic regression to derive the CIRAS model based on these variables: ascites discomfort score (≤50 or >50), plasma sodium (≥140, 133-139, 125-132, or <125 mmoL/L), and a composite of ascites accumulation and diuretic treatment. We validated the prediction model in 697 trial participants randomized to satavaptan treatment. The 1-year all-cause mortality was 19.6%. The area under the receiver operator curve was higher for the CIRAS model than for the standard ascites classification into refractory and diuretic-responsive in both the development cohort (0.68 [95% confidence interval (CI): 0.62-0.75] vs. 0.62 [0.57-0.68]), and the validation cohort (0.68 [0.64-0.72] vs. 0.55 [0.51-0.60]). The CIRAS model had similar discrimination to the Child-Pugh score and nearly as good as the Model for End-Stage Liver Disease (MELD), MELD-Na, and MELD 3.0. Conclusions: The CIRAS model based on simple ascites-relevant data is an easily applicable and patient-centered way to describe the severity and prognosis of all ascites grades. It carries more prognostic information than today's label of "refractory ascites" and forms the basis for earlier and better clinical decisions related to ascites management.
腹水形成是肝硬化失代偿的标志，并预示着预后不良。广泛使用的腹水利尿剂反应性或难治性的标准二分法不能涵盖腹水的范围，并且预后信息有限。我们开发了肝硬化腹水严重程度（CIRAS）模型，以预测在 satavaptan 试验中随机分配到安慰剂的 465 名患者的 1 年死亡率，这些试验旨在研究肝硬化腹水的治疗。我们使用多变量逻辑回归基于以下变量得出 CIRAS 模型：腹水不适评分（≤50 或 >50）、血浆钠（≥140、133-139、125-132 或 <125mmol/L）以及腹水积聚和利尿剂治疗的综合评分。我们在 697 名随机接受 satavaptan 治疗的试验参与者中验证了该预测模型。1 年全因死亡率为 19.6%。在发展队列和验证队列中，CIRAS 模型的受试者工作特征曲线下面积均高于标准腹水分类（难治性和利尿剂反应性），分别为 0.68（95%置信区间：0.62-0.75）和 0.62（0.57-0.68），0.68（0.64-0.72）和 0.55（0.51-0.60）。CIRAS 模型的区分度与 Child-Pugh 评分相似，与 MELD、MELD-Na 和 MELD 3.0 相似。结论：基于简单腹水相关数据的 CIRAS 模型是一种易于应用且以患者为中心的方法，可以描述所有腹水程度的严重程度和预后。它比目前的“难治性腹水”标签提供了更多的预后信息，并为与腹水管理相关的更早和更好的临床决策提供了基础。
