Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis

NCT03163745 | Completed

• 1 other identifier: ASBP
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 days

Other Outcomes (1)

• Assess the efficacy of treatment in these asymptomatic patients

  2 days

Study Arms (1)

Asymptomatic spontaneous bacterial peritonitis

All the included patients will be subjected to: 1. Full medical History and physical examination 2. Laboratory investigations: Complete blood picture , kidney function tests, liver function tests ,prothrombin time and concentration 3. Abdominal Ultrasound 4. 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

Interventions

paracentesis PROCEDURE

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

Asymptomatic spontaneous bacterial peritonitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Al-RAhjhy Assuit unviersity hospital

Asyut, Assuit, 777771, Egypt

Location

Related Publications (9)

• 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.

  PMID: 17854593 RESULT

• 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.

  PMID: 19266595 RESULT

• 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.

  PMID: 19475696 RESULT

• 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.

  PMID: 20513645 RESULT

• Sheer TA, Runyon BA. Spontaneous bacterial peritonitis. Dig Dis. 2005;23(1):39-46. doi: 10.1159/000084724.

  PMID: 15920324 RESULT

• 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.

  PMID: 16979776 RESULT

• 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.

  PMID: 17464969 RESULT

• 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.

  PMID: 21536540 RESULT

• 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.

  PMID: 23556041 RESULT

MeSH Terms

Interventions

Paracentesis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antony Georgy, MBBCh

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AssiutU

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 23, 2017
• Study Start: March 11, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 26, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

EG (1)