Skip to main content
OpenTrials
Completed

NCT Number: NCT03163745

Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spontaneous Bacterial Peritonitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-RAhjhy Assuit unviersity hospital

Asyut, Assuit, 777771, Egypt

About this study

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%) .

A french study was done in 2013 in asymptomatic cirrhotic outpatients and found that the incidence of asymptomatic Spontaneous bacterial peritonitis was only 1.2% .

Another study was done in Pakistan in 2015 and found that the incidence of asymptomatic spontaneous bacterial peritonitis in outpatient patient with cirrhosis was 10%(8 out of 80).

Another Egyptian study was done in 2016 on asymptomatic spontaneous bacterial peritonitis in adult Egyptian patient with decompensated cirrhosis and found that 21 (13%) patient was asymptomatic spontaneous bacterial peritonitis out of 160 cirrhotic patient ascetic patient who fulfill the inclusion criteria .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Paracentesis

Procedure

paracentesis will be done for all patient for ascitic fluid study and ascitic fluid culture

Primary outcomes

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

    Time frame: 2 days

    Number of asymptomatic spontaneous bacterial peritonitis

Secondary outcomes

  1. Determine the causative organisms of asymptomatic spontaneous bacterial peritonitis..

    Time frame: 2 days

    making ascitic fluid culture

Other outcomes

  1. Assess the efficacy of treatment in these asymptomatic patients

    Time frame: 2 days

    Patients whose results will confirm spontaneous bacterial peritonitis will receive treatment in the form of Cefotaxime 2gm/12 hours and then follow up by ascitic fluid testing will be done again

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.