Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome

Ascites Clinical Trial

Official title:

Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490217
• Other study ID #: R065585-1
• Status: Completed
• Phase: N/A
• First received: June 21, 2007
• Last updated: June 21, 2007
• Start date: December 1993
• Est. completion date: March 2007

Study information

• Verified date: June 2007
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Spontaneous bacterial peritonitis (SBP) is a severe complication of ascites in cirrhotic patients. Under clinical experience, this condition seems to be more uncommon in Finland. The aim of this study was to measure the incidence of SBP in consecutive patients with ascites requiring hospitalization in a Finnish University Hospital.

Description:

Spontaneous bacterial peritonitis (SBP) is a complication of liver cirrhosis with high mortality and low survival rates. The incidence of SBP is reported to range from 11-35% in patients with ascites requiring hospitalization. Under clinical experience, the incidence of SBP in Finland seems to be lower than reported elsewhere. Alcohol is the dominant etiologic factor of liver cirrhosis in Finland (90%), which might be a factor affecting the incidence of SBP. The aim of this study is to measure the incidence of SBP in Finland. We included consecutive patients who underwent diagnostic paracentesis for ascites in Tampere University Hospital during 2/1994 - 12/1998 and 1/2005 - 3/2007. Spontaneous bacterial peritonitis was diagnosed when the ascitic fluid contained over 250 polymorphonuclear cells / mm^3 regardless of culture and with no evidence of intra-abdominal source of infection e.g. an abscess or a perforation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnostic paracentesis performed during the study period

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Ascites
• Peritonitis
• Primary Peritonitis
• Spontaneous Bacterial Peritonitis

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
University of Tampere

Country where clinical trial is conducted

Finland,