drugset / Trial / NCT00852800

Low-dose Albumin Solution in SBP: a Randomized Double-blind Pilot Study

NCT00852800

Phase 2 Unknown 43 enrolled Hospital de Clinicas de Porto Alegre
RandomizedParallel-groupQuadruple-blindTreatment

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 patients, with high mortality. Intravenous albumin (1.5 g/kg at diagnosis and 1 g/kg 48 hours later - standard regimen) helps to prevent HRS and improves survival. No information exists on the efficacy of lower doses of albumin. This study was designed to allow direct comparison among different doses of intravenous albumin in patients with SBP - standard (SR) vs dose reduced regimen (DRR) - in order to prevent renal failure and mortality.

Timeline

Start
2006-03
Primary completion
2009-08
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 0.5 g/kg Intravenous
Subject Albumin Protein / enzyme biologic 1 g/kg Intravenous