Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03163745
Collaborator
(none)
70
1
14.5
4.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: paracentesis

Detailed Description

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 .

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis in Upper Egypt : A Prospective Hospital Based Study
Actual Study Start Date :
Mar 11, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
May 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Asymptomatic spontaneous bacterial peritonitis

All the included patients will be subjected to: Full medical History and physical examination Laboratory investigations: Complete blood picture , kidney function tests, liver function tests ,prothrombin time and concentration Abdominal Ultrasound Ascitic fluid paracentesis will be done to test for total leucocyte count and polymorphonuclear count , total protein and albumin levels. Testing for cytological analysis and culture will be done.

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

Outcome Measures

Primary Outcome Measures

  1. assess the frequency of asymptomatic spontaneous bacterial peritonitis in patient with decompensated liver cirrhosis admitted to Al-Rajhi Liver Hospital [2 days]

    Number of asymptomatic spontaneous bacterial peritonitis

Secondary Outcome Measures

  1. Determine the causative organisms of asymptomatic spontaneous bacterial peritonitis.. [2 days]

    making ascitic fluid culture

Other Outcome Measures

  1. Assess the efficacy of treatment in these asymptomatic patients [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:
  1. Symptomatic spontaneous bacterial peritonitis (patients with fever, abdominal pain or tenderness, leucocytosis, hepatic encephalopathy, impaired renal function)

  2. Patients taking antibiotics for any other infections within 2 weeks e.g. pneumonia, urinary tract infection..etc

  3. Patients taking antibiotics as prophylaxis for spontaneous bacterial peritonitis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al-RAhjhy Assuit unviersity hospital Assiut Assuit Egypt 777771

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Antony Georgy, MBBCh, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antony Albair Georgy, AssiutU, Assiut University
ClinicalTrials.gov Identifier:
NCT03163745
Other Study ID Numbers:
  • ASBP
First Posted:
May 23, 2017
Last Update Posted:
Nov 19, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2020