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

2026년 7월 25일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

100

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

해당 없음

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
28-Day All-Cause Mortality Rate
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
In-Hospital All-Cause Mortality Rate
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 9월 1일

연구 등록 날짜

최초 제출

2026년 7월 25일

QC 기준을 충족하는 최초 제출

2026년 7월 25일

처음 게시됨 (실제)

2026년 7월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 25일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Predicting Outcomes in ACLF

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