Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
The core of the proposal is a prospective, randomized, double-blinded, controlled study which
will compare the efficacy of dextran 70 versus human albumin in the treatment of cirrhotic
patients with spontaneous bacterial peritonitis (SBP). Because dextran 70, which is FDA
approved for plasma volume expansion, is significantly less expensive than human albumin,
this study is designed and powered to determine if dextran 70 is equivalent in clinical
efficacy when compared to albumin.
Specific aims for this project are to:
1. Assess the effect of plasma volume expansion with dextran 70 on disease-specific
mortality at 30 days in cirrhotic patients with spontaneous bacterial peritonitis
compared to plasma volume expansion with human albumin.
2. Assess the effect of dextran 70 compared to human albumin on the prevention of renal
dysfunction within 30-days of diagnosis of SBP, as measured by the calculated creatinine
clearance, plasma renin activity, serum aldosterone levels, levels of brain natriuretic
peptide, and further development of the hepatorenal syndrome in cirrhotic patients with
spontaneous bacterial peritonitis.
3. Compare the survival to liver transplantation, treatment costs, hospitalization costs,
resource utilization, and quality of life of patients with spontaneous bacterial
peritonitis treated with dextran 70 and human albumin in the 30 days following
diagnosis.
4. Establish a comprehensive tissue bank of blood, ascites, and urine in patients with
spontaneous bacterial peritonitis for future testing and translational research.
5. Establish a clinical electronic database with web-based data entry and remote analysis
capabilities linking tissue bank samples and patient outcomes related to the above
clinical trials.
Phase:
Phase 4
Details
Lead Sponsor:
University of Virginia
Collaborator:
American Association for the Study of Liver Diseases