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Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome

This study has been completed.
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00490217
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition
Spontaneous Bacterial Peritonitis
Primary Peritonitis
Ascites

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Tampere:

Enrollment: 240
Study Start Date: December 1993
Study Completion Date: March 2007
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic paracentesis performed during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490217

Locations
Finland
Tampere University Hospital
Tampere, Pirkanmaa, Finland
Sponsors and Collaborators
University of Tampere
Investigators
Principal Investigator: Jahangir A Khan, MS Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
Study Director: Pekka Collin, MD Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
Study Director: Pekka Pikkarainen, MD Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00490217     History of Changes
Other Study ID Numbers: R065585-1
Study First Received: June 21, 2007
Last Updated: June 21, 2007
Health Authority: Finland: Ethics Committee

Keywords provided by University of Tampere:
Spontaneous bacterial peritonitis
incidence
Finland
etiology
liver cirrhosis

Additional relevant MeSH terms:
Ascites
Peritonitis
Pathologic Processes
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013