Spontaneous Bacterial PeritonitisNCT00490217
Spontaneous Bacterial Peritonitis: Incidence, Risk Factors and Outcome
An observational study of Spontaneous Bacterial Peritonitis and Primary Peritonitis, run by Tampere University at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spontaneous Bacterial Peritonitis, Primary Peritonitis, Ascites
- How many people
- 240 participants
- Where
- 1 siteFinland
- Study dates
- Dec 1993to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnostic paracentesis performed during the study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Spontaneous bacterial peritonitis, incidence, Finland, etiology, liver cirrhosis
- Medical subject headings
- Peritonitis, Ascites, Liver Cirrhosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startDec 1993
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Bacterial PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Investigators
- Jahangir A Khan, MS, Principal investigator, Department of Gastroenterology and Alimentary Tract Surgery, Tampere University HospitalPekka Collin, MD, Study director, Department of Gastroenterology and Alimentary Tract Surgery, Tampere University HospitalPekka Pikkarainen, MD, Study director, Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490217
- Sponsor's protocol ID
- R065585-1
- Status last verified
- Jun 2007
- First submitted
- 21 Jun 2007
- Last updated
- 22 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaani Bakterielli Peritoniitti: Esiintyvyys, riskitekijät ja Vaikutus Ennusteeseen
- ClinicalTrials.gov ID
- NCT00490217
- Acronym / sponsor ID
- R065585-1
- Keywords
- Spontaneous bacterial peritonitis, incidence, Finland, etiology, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Dec 1993
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnostic paracentesis performed during the study period
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2007.
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Prediction of SBP in Cirrhotic Patients by Platlet Count, Na and AlBl Index.
Spontaneous Bacterial Peritonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jahangir A Khan, MS principal investigator
Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
Pekka Collin, MD study director
Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
Pekka Pikkarainen, MD study director
Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Bacterial Peritonitis and Primary Peritonitis, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2007.