- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00490217
Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome
June 21, 2007 updated by: Tampere University
Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pirkanmaa
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Tampere, Pirkanmaa, Finland
- Tampere University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnostic paracentesis performed during the study period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Other
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1993
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
June 21, 2007
First Submitted That Met QC Criteria
June 21, 2007
First Posted (Estimate)
June 22, 2007
Study Record Updates
Last Update Posted (Estimate)
June 22, 2007
Last Update Submitted That Met QC Criteria
June 21, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R065585-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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