Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis

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

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

Study Overview

• Status: Completed
• Conditions: Spontaneous Bacterial Peritonitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, 777771
      • Al-RAhjhy Assuit unviersity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients with decompensated liver cirrhosis with ascites (Child B and C) admitted to to AL-RAJHI LIVER HOSPITAL in assuit university for any cause other than symptomatic bacterial peritonitis(patient with fever , abdominal pain , or tenderness, leucocytosis, hepatic encephalopathy, impaired renal function) or taking antibiotics for any other infections within 2 weeks e.g. pneumonia, urinary tract infection..etc, or Patients taking antibiotics as prophylaxis for spontaneous bacterial peritonitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the frequency of asymptomatic spontaneous bacterial peritonitis in patient with decompensated liver cirrhosis admitted to Al-Rajhi Liver Hospital	Number of asymptomatic spontaneous bacterial peritonitis	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the causative organisms of asymptomatic spontaneous bacterial peritonitis..	making ascitic fluid culture	2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the efficacy of treatment in these asymptomatic patients	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	2 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Antony Georgy, MBBCh, Assiut University

Publications and helpful links

General Publications

• Fernandez J, Navasa M, Planas R, Montoliu S, Monfort D, Soriano G, Vila C, Pardo A, Quintero E, Vargas V, Such J, Gines P, Arroyo V. Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis. Gastroenterology. 2007 Sep;133(3):818-24. doi: 10.1053/j.gastro.2007.06.065. Epub 2007 Jul 3.
• Koulaouzidis A, Bhat S, Saeed AA. Spontaneous bacterial peritonitis. World J Gastroenterol. 2009 Mar 7;15(9):1042-9. doi: 10.3748/wjg.15.1042.
• Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available.
• Pluta A, Gutkowski K, Hartleb M. Coagulopathy in liver diseases. Adv Med Sci. 2010;55(1):16-21. doi: 10.2478/v10039-010-0018-3.
• Sheer TA, Runyon BA. Spontaneous bacterial peritonitis. Dig Dis. 2005;23(1):39-46. doi: 10.1159/000084724.
• Riordan SM, Williams R. The intestinal flora and bacterial infection in cirrhosis. J Hepatol. 2006 Nov;45(5):744-57. doi: 10.1016/j.jhep.2006.08.001. Epub 2006 Sep 1. No abstract available.
• Nousbaum JB, Cadranel JF, Nahon P, Khac EN, Moreau R, Thevenot T, Silvain C, Bureau C, Nouel O, Pilette C, Paupard T, Vanbiervliet G, Oberti F, Davion T, Jouannaud V, Roche B, Bernard PH, Beaulieu S, Danne O, Thabut D, Chagneau-Derrode C, de Ledinghen V, Mathurin P, Pauwels A, Bronowicki JP, Habersetzer F, Abergel A, Audigier JC, Sapey T, Grange JD, Tran A; Club Francophone pour l'Etude de l'Hypertension Portale; Association Nationale des Hepato-Gastroenterologues des Hopitaux Generaux de France. Diagnostic accuracy of the Multistix 8 SG reagent strip in diagnosis of spontaneous bacterial peritonitis. Hepatology. 2007 May;45(5):1275-81. doi: 10.1002/hep.21588.
• Kasztelan-Szczerbinska B, Slomka M, Celinski K, Serwacki M, Szczerbinski M, Cichoz-Lach H. Prevalence of spontaneous bacterial peritonitis in asymptomatic inpatients with decompensated liver cirrhosis - a pilot study. Adv Med Sci. 2011;56(1):13-7. doi: 10.2478/v10039-011-0010-6.
• Cadranel JF, Nousbaum JB, Bessaguet C, Nahon P, Nguyen-Khac E, Moreau R, Thevenot T, Silvain C, Bureau C, Nouel O, Pilette C, Paupard T, Pauwels A, Sapey T, Grange JD, Tran A. Low incidence of spontaneous bacterial peritonitis in asymptomatic cirrhotic outpatients. World J Hepatol. 2013 Mar 27;5(3):104-8. doi: 10.4254/wjh.v5.i3.104.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): May 26, 2020

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 21, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Liver Diseases; Fibrosis; Intraabdominal Infections; Liver Cirrhosis; Peritonitis
• Other Study ID Numbers: ASBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No