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Evaluating Novel Scoring Systems to Predict Outcomes in Acute-on-Chronic Liver Failure

2026年7月25日 更新者:Rehab Hassan Abdel-hafiz Hassan、Assiut University

Evaluation of Novel Scores for Prediction of Outcomes in Patients With Acute-on-Chronic Liver Failure

Acute-on-chronic liver failure (ACLF) is a serious condition where a patient with long-term liver disease suddenly experiences severe liver worsening and failure of other organ systems, such as the kidneys or lungs. ACLF is associated with a high risk of short-term death, making early and accurate prediction of patient outcomes essential for guiding medical decisions.

Conventional scoring systems, such as the Child-Pugh and Model for End-Stage Liver Disease Sodium (MELD-Na) scores, are widely used to assess liver disease severity. However, these traditional models may not fully capture the intense systemic inflammation and multiorgan failure characteristic of ACLF. Recently, novel prognostic scoring models, specifically the CLIF-C ACLF-D score and the MELD-complication score, have been developed to better predict patient outcomes by integrating markers of inflammation, organ dysfunction, and clinical complications.

This study aims to evaluate and validate the clinical usefulness of these novel scoring models compared to conventional scores in predicting in-hospital and 28-day mortality among patients admitted with ACLF.

Participants enrolled in this prospective observational study will be recruited from the Intensive Care Unit (ICU) of the Tropical Medicine and Gastroenterology Department at Al-Rajhi University Hospital. Upon admission, participants will undergo routine clinical examinations, laboratory testing, and imaging. The various risk scores will be calculated at baseline. Participants will be monitored throughout their hospital stay, and their survival status will be followed for 28 days after admission to compare the accuracy of each scoring system.

研究概览

详细说明

Acute decompensation in liver cirrhosis is the primary cause of hospitalization among cirrhotic patients. Acute-on-chronic liver failure (ACLF) represents a distinct, severe clinical entity characterized by systemic inflammation, single- or multiple-organ failures, and high short-term mortality. While traditional scoring systems like the Child-Pugh and Model for End-Stage Liver Disease Sodium (MELD-Na) scores are routinely utilized, they may fail to capture the complex inflammatory response and multiorgan involvement inherent to ACLF.

To improve prognostic estimation, novel predictive tools, including the CLIF-C ACLF-D score and the MELD-complication score, have been introduced, incorporating inflammatory parameters and complication markers. Validation of these prognostic models across distinct patient populations is necessary prior to broad implementation. This study evaluates the prognostic performance of these novel models in patients with ACLF admitted to the Intensive Care Unit (ICU).

All enrolled participants will undergo systematic evaluation upon admission:

  1. Clinical and Demographic Assessment: Full patient history (demographics, etiology of underlying chronic liver disease, previous episodes of decompensation, drug history) and comprehensive physical examination (vital signs, grade of hepatic encephalopathy, jaundice, asterixis, edema, and clinical signs of infection or ascites/pleural effusion).
  2. Laboratory Diagnostics: Complete blood count with differential, liver function tests (total and direct bilirubin, serum albumin), renal function parameters (serum creatinine, blood urea nitrogen), coagulation profile (prothrombin time, INR), serum electrolytes (sodium, potassium), C-reactive protein (CRP), arterial blood gas analysis, viral hepatitis markers (HBsAg, anti-HCV), ascitic fluid analysis (if applicable), and biological cultures from suspected infectious foci.
  3. Imaging: Abdominal ultrasonography (evaluating hepatic architecture, portal vein parameters, splenic dimensions, collateral circulation, biliary structure, renal status, ascites) and chest radiography.
  4. Scoring Calculation: Baseline risk scores-including Child-Pugh, MELD-Na, CLIF-C OF, CLIF-C ACLF, CLIF-C ACLF-D, and MELD-complication scores-will be calculated at admission using standard mathematical formulas and validated online platforms.

Participants will be followed throughout their hospital stay and up to 28 days following admission. Survival outcomes will be confirmed in-hospital or post-discharge via telephone follow-up or clinical visits.

研究类型

观察性的

注册 (估计的)

100

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

Patients diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to the EASL-CLIF diagnostic criteria who are admitted to the Intensive Care Unit (ICU) of the Tropical Medicine and Gastroenterology Department at Al-Rajhi University Hospital.

描述

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Diagnosed with Acute-on-Chronic Liver Failure (ACLF) fulfilling the diagnostic criteria according to EASL-CLIF.
  • Admitted to the Intensive Care Unit (ICU) of the Tropical Medicine and Gastroenterology Department, Al-Rajhi University Hospital.

Exclusion Criteria:

  • Patients with hepatocellular carcinoma.
  • Patients with advanced extrahepatic malignancy.
  • Pregnant females.
  • Patients younger than 18 years old.
  • Patients with incomplete clinical or laboratory data.
  • Patients or first-degree relatives refusing participation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
ACLF Patients
Patients aged 18 years or older diagnosed with Acute-on-Chronic Liver Failure (ACLF) according to EASL-CLIF criteria and admitted to the Intensive Care Unit of the Tropical Medicine and Gastroenterology Department at Al-Rajhi University Hospital. All patients will undergo full clinical, laboratory, and radiological evaluations at baseline, followed by calculation of novel (CLIF-C ACLF-D, MELD-complication) and conventional (Child-Pugh, MELD-Na, CLIF-C ACLF) prognostic scores to predict short-term outcomes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
28-Day All-Cause Mortality Rate
大体时间:28 days post-hospital admission
Percentage of participants with Acute-on-Chronic Liver Failure (ACLF) who die from any cause within 28 days following hospital admission. Survival status will be evaluated during the hospital stay and confirmed post-discharge via clinic visits or telephone follow-up.
28 days post-hospital admission

次要结果测量

结果测量
措施说明
大体时间
In-Hospital All-Cause Mortality Rate
大体时间:From date of hospital admission up to hospital discharge, assessed up to 28 days
Percentage of participants with Acute-on-Chronic Liver Failure (ACLF) who die from any cause during their hospital stay.
From date of hospital admission up to hospital discharge, assessed up to 28 days
Prognostic Performance of the CLIF-C ACLF-D Score for 28-Day Mortality
大体时间:Baseline (day 1 of admission) up to 28 days
Predictive accuracy of the novel CLIF-C ACLF-D score measured by the Area Under the Receiver Operating Characteristic Curve (AUROC) to predict 28-day all-cause mortality.
Baseline (day 1 of admission) up to 28 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年7月25日

首先提交符合 QC 标准的

2026年7月25日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月25日

最后验证

2026年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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