Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome
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| First Received Date ICMJE | June 21, 2007 | ||||||||||||
| Last Updated Date | June 21, 2007 | ||||||||||||
| Start Date ICMJE | December 1993 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | No Changes Posted | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome | ||||||||||||
| Official Title ICMJE | Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen | ||||||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Not Provided | ||||||||||||
| Study Population | Not Provided | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 240 | ||||||||||||
| Completion Date | March 2007 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | Not Provided | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Finland | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00490217 | ||||||||||||
| Other Study ID Numbers ICMJE | R065585-1 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | University of Tampere | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Tampere | ||||||||||||
| Verification Date | June 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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