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临床试验/NCT07024355
NCT07024355尚未招募不适用

Predicting and Monitoring Spontaneous Bacterial Peritonitis in Cirrhotic Patients Using the Mansoura Scoring System

Assiut University0 个研究点目标入组 250 人开始时间: 2026年4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
250
主要终点
Proportion of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP)

研究概览

简要总结

The aim of this prospective study was to examine predictors of SBP in order to develop a noninvasive method to identify or exclude an episode of SBP, for starting early treatment with antibiotics, so decrease morbidity and mortality in these patients.

详细描述

Spontaneous bacterial peritonitis (SBP) is a bacterial infection of ascitic fluid without any intra-abdominal, surgically treatable cause.

SBP is the most common bacterial infection in patients with cirrhosis, with a mortality rate exceeding 90% in untreated cases. However, inpatient mortality has been reduced to about 20% with early diagnosis and effective treatment.

Delayed diagnosis increases in-hospital mortality; with each hour of delay in performing paracentesis for SBP diagnosis, mortality increases by approximately 3.3%.

A study conducted in the United States reported that paracentesis was performed within the first 24 hours of admission in only 66% of cirrhotic patients with ascites.

Another study noted that routine paracentesis cannot be performed in all patients with liver cirrhosis. Therefore, delaying diagnosis increases mortality, and it is necessary to find a non-invasive and accurate method for predicting SBP.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged >18 years
  • Diagnosed liver cirrhosis
  • Presence of ascites
  • Provided written informed consent

排除标准

  • Use of antibiotics within the previous two weeks
  • Prophylactic treatment for spontaneous bacterial peritonitis (SBP) prior to admission
  • Ascites not related to portal hypertension, including:
  • Peritoneal tuberculosis
  • Peritoneal carcinomatosis
  • Congestive heart failure
  • Renal disease
  • Pancreatitis
  • Hemorrhagic ascites
  • Secondary peritonitis
  • Presence of infections other than SBP, including:
  • Pneumonia
  • Urinary tract infection
  • Skin and soft tissue infection
  • Presence of malignancy Hematologic diseases
  • Use of antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Receipt of platelet or blood transfusion prior to admission
  • Diseases associated with elevated mean platelet volume (MPV), including:
  • Diabetes mellitus
  • Cardiovascular disease
  • Hyperthyroidism
  • Immune thrombocytopenia
  • Myeloproliferative disorders

结局指标

主要结局

Proportion of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP)

时间窗: At hospital admission( within 24 hours)

Primary Outcome Measures Primary Outcome Measure 1: Title: Number of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP).The score ranges from 0 to 4, with higher scores indicating a higher likelihood of SBP (worse outcome). A score ≥4 is considered suggestive of SBP Time Frame: At hospital admission (within 24 hours) Description: Count of patients with a Mansoura score ≥4 who are diagnosed with spontaneous bacterial peritonitis (SBP), defined as ascitic fluid neutrophil count \>250 cells/mm³. Unit of Measure: Number of patients Primary Outcome Measure 2: Title: Proportion of Patients With Mansoura Score ≥4 Diagnosed With Spontaneous Bacterial Peritonitis (SBP) Time Frame: At hospital admission (within 24 hours) Description: Proportion of patients with a Mansoura score ≥4 who are diagnosed with spontaneous bacterial peritonitis (SBP), expressed as a percentage of total study participants. Unit of Measure: Percentage of participants.

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

Amira Mohammed Abdel Mowgod

Principle Investigator

Assiut University

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