Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis
NCT ID: NCT03163745
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2019-03-11
2020-05-26
Brief Summary
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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
Detailed Description
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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 .
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
paracentesis
paracentesis will be done for all patient for ascitic fluid study and ascitic fluid culture
Interventions
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paracentesis
paracentesis will be done for all patient for ascitic fluid study and ascitic fluid culture
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Antony Albair Georgy
AssiutU
Principal Investigators
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Antony Georgy, MBBCh
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Locations
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Al-RAhjhy Assuit unviersity hospital
Asyut, Assuit, Egypt
Countries
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References
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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.
Other Identifiers
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ASBP
Identifier Type: -
Identifier Source: org_study_id