Status:
UNKNOWN
Low-dose Albumin Solution in SBP: a Randomized Double-blind Pilot Study
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Renal Impairment
All Cause Mortality
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Spontaneous bacterial peritonitis (SBP) is a common and severe complication of cirrhosis. The most serious complication of SBP is the hepatorenal syndrome (HRS), which occurs in up to 30 percent of pa...
Detailed Description
Patients with cirrhosis who had spontaneous bacterial peritonitis (SBP) and who are admitted from March 2006 to a single university hospital were evaluated for inclusion in the study. The study was ap...
Eligibility Criteria
Inclusion
- cytological diagnosis of spontaneous bacterial peritonitis
- age between 18 and 80 years
- written informed consent
Exclusion
- findings suggestive of secondary peritonitis
- antibiotic treatment within one week before the diagnosis of spontaneous bacterial peritonitis (except for prophylactic treatment with norfloxacin or trimethoprim/sulfamethoxazole)
- other infections, shock, gastrointestinal bleeding, grade 3 or 4 hepatic encephalopathy, cardiac failure, and any disease (e.g., advanced neoplasia) that could affect the short term prognosis
- creatinine level of more than 3 mg per deciliter
- potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment) within one week before the diagnosis of peritonitis
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00852800
Start Date
March 1 2006
End Date
March 1 2011
Last Update
June 7 2010
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903