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临床试验/NCT03163745
NCT03163745已完成不适用

Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis in Upper Egypt : A Prospective Hospital Based Study

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
assess the frequency of asymptomatic spontaneous bacterial peritonitis in patient with decompensated liver cirrhosis admitted to Al-Rajhi Liver Hospital

研究概览

简要总结

Spontaneous bacterial peritonitis is defined as the presence of an infection in a previously sterile ascites in the absence of an intra-abdominal source of infection or malignancy .

The variants of Spontaneous bacterial peritonitis includes - (i) Classic Spontaneous bacterial peritonitis: -ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3 and positive culture. (ii) Culture negative neutrocytic ascitis but the ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3 and (iii) Bacterascites: - a culture positive ascitic fluid but the polymorphonuclear leukocyte counts less than 250/mm3

详细描述

Spontaneous bacterial peritonitis is a serious complication in patient with decompensated liver cirrhosis . The incidence in ascetic patients varies between 7-30 % as a consequence result of impaired defense mechanism and increased susceptibility to bacterial infection in cirrhotic patients with ascites Spontaneous bacterial peritonitis may complicated by hepatorenal syndrome or systemic sepsis and has high recurrence rate - estimated as approximately 70% within 1 year of follow up .

The clinical detection of spontaneous bacterial peritonitis requires a high index of suspicion because symptoms and signs of infection are obscure in most of patients.

About 13% of patients are asymptomatic and a few studies reported the incidence of asymptomatic spontaneous bacterial peritonitis in cirrhotic patients with ascites The most common clinical manifestations defined by Jeffries et al and Castellote et al in 2007 are: temperature above 38 °C or below 36.5 °C, chills, abdominal tenderness suggestive of peritonitis, developing or worsening hepatic encephalopathy, acute renal failure (defined by an increase in the serum creatinine level to above 133 μmol/L) and arterial hypotension (systolic arterial pressure below 80 mmHg).

The American Association for the Study of Liver Diseases recommends performing exploratory paracentesis in each patient with cirrhosis and ascites .

A study was done in Poland in 2011, shows the prevalence of spontaneous bacterial peritonitis in asymptomatic inpatients with decompensated liver cirrhosis and found that two of 37 asymptomatic cirrhotics who were included in the study met criteria of asymptomatic spontaneous bacterial peritonitis (5%) .

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with decompensated liver cirrhosis with ascites (Child B and C) regardless of the etiology of liver cirrhosis

排除标准

  • Symptomatic spontaneous bacterial peritonitis (patients with fever, abdominal pain or tenderness, leucocytosis, hepatic encephalopathy, impaired renal function)
  • Patients taking antibiotics for any other infections within 2 weeks e.g. pneumonia, urinary tract infection..etc
  • Patients taking antibiotics as prophylaxis for spontaneous bacterial peritonitis

结局指标

主要结局

assess the frequency of asymptomatic spontaneous bacterial peritonitis in patient with decompensated liver cirrhosis admitted to Al-Rajhi Liver Hospital

时间窗: 2 days

Number of asymptomatic spontaneous bacterial peritonitis

次要结局

  • Determine the causative organisms of asymptomatic spontaneous bacterial peritonitis..(2 days)

研究者

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

Antony Albair Georgy

AssiutU

Assiut University

研究点 (1)

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