Clinical Trial: Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
Brief 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:
- 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.
- 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.
- 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.
- Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research.
- Establish a clinical electronic database with web-based data entry and remote analysis capabilities linking tissue bank samples an
Detailed Summary:
All patients admitted to the University of Virginia Health system who have clinically or pathologically defined cirrhosis, laboratory evidence consistent with spontaneous bacterial peritonitis and clinically or radiologically accessible ascites will be screened for participation in this prospective,randomized, double-blinded, controlled trial. All patients agreeing to participate will be treated with the standard of care antibiotic and supportive therapy and will be randomized to one of two treatment regimens. Treatment arm one will consist of human albumin, 1.5 g/kg intravenously administered at the time of enrollment and 1.0 g/kg administered on day three after enrollment. Treatment arm two will consist of dextran 70, 1.0 g/kg intravenously daily for three days. Under separate informed consent from the therapeutic portion of the study, all participants will be offered enrollment into the tissue repository and prospective outcomes database. Upon consent to enroll in the repository and database, serum, ascites, and urine will be collected from participating subjects for storage and future evaluation of inflammatory and pathophysiologic factors contributing to the morbidity and mortality of SBP and HRS. Prospectively collected clinical and outcomes data will be recorded into a perpetual electronic database for future comprehensive outcomes and translational studies. Participation in either the tissue repository or perpetual clinical database will not be compulsory to enroll in the therapeutic or prophylaxis trials. Similarly, subjects can choose not be enrolled in either the database or tissue repository.
Comprehensive treatment costs incurred in both treatment arms will be collected prospectively by study personnel and used to perform a formal cost-effectiveness analysis. Micro-costing algorithms will be used to derive direct treatment and hospitalization costs for the tw
Sponsor: University of Virginia
Current Primary Outcome: 30 Day All Cause Mortality [ Time Frame: 30 days ]
30 day all cause mortality
Original Primary Outcome: All cause mortality [ Time Frame: 30 days ]
Current Secondary Outcome:
Original Secondary Outcome: Composite endpoint of 30 day survival, survival to liver transplantation, prevention of the hepatorenal syndrome, and resolution of clinical infection [ Time Frame: 30 day ]
Information By: University of Virginia
Dates:
Date Received: December 10, 2007
Date Started: June 2007
Date Completion:
Last Updated: December 1, 2014
Last Verified: December 2014
