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临床试验/NCT07116369
NCT07116369尚未招募不适用

Enhancing Prediction of Spontaneous Bacterial Peritonitis in Liver Cirrhosis by Integrating Serum Sodium and Platelet Count With the Albumin-Bilirubin Score .

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Occurrence of SBP, ALBI score, s.sodium, platelet count

研究概览

简要总结

This study aims to evaluate whether integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score can improve the early prediction of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. SBP is a common and potentially life-threatening complication of cirrhosis. Identifying at-risk patients early using simple, routine laboratory parameters could enhance risk stratification, guide monitoring strategies, and reduce associated morbidity and mortality.

Participants will be Adult patients (≥18 years) with liver cirrhosis and ascites undergoing diagnostic paracentesis at Sohag University Hospital.

详细描述

This is a prospective observational study designed to enhance the prediction of spontaneous bacterial peritonitis (SBP) in patients with liver cirrhosis and ascites by integrating serum sodium levels and platelet count with the Albumin-Bilirubin (ALBI) score. SBP remains a serious and potentially fatal complication in cirrhotic patients, with delayed diagnosis contributing to poor outcomes. The ALBI score, which reflects liver function objectively, along with hyponatremia and thrombocytopenia-common in cirrhosis-may provide a simple, low-cost method for early identification of patients at high risk for SBP.

The study will be conducted over 6 months at the Internal Medicine and Hepatology Units, Sohag University Hospital. All eligible adult patients (≥18 years) with liver cirrhosis and ascites who undergo diagnostic paracentesis will be screened for inclusion.

Inclusion criteria include cirrhotic patients with ascites undergoing diagnostic paracentesis.

Exclusion criteria include secondary peritonitis, advanced hepatocellular carcinoma, obstructive jaundice, recent antibiotic use (<7 days), end-stage renal disease requiring dialysis, current use of immunosuppressive therapy, and incomplete data.

Each participant will undergo clinical evaluation and laboratory testing, including serum albumin, bilirubin (for ALBI calculation), sodium, and platelet count. Ascitic fluid analysis will be performed to diagnose SBP based on PMN count ≥250 cells/mm³.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients (≥18 years) with liver cirrhosis and ascites who underwent diagnostic paracentesis.

排除标准

  • obstructive jaundice
  • Recent antibiotic use < 7 days
  • Secondary pertonitis (bowel perforation)
  • Advanced Hepatocelluar carcinoma
  • End-stage renal disease requiring dialysis
  • Use of immunosuppressive therapy
  • Incomplete laboratory or clinical data.

结局指标

主要结局

Occurrence of SBP, ALBI score, s.sodium, platelet count

时间窗: Within 1 week

Outcome of SBP in cirrhotic patients by measurement of ALBI score, platelet count and s.sodium

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Helmy Mahmoud

Internal Medicine Resident Doctor

Sohag University

研究点 (1)

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