Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00570960|
Recruitment Status : Terminated (drug product became unavilable)
First Posted : December 11, 2007
Results First Posted : December 3, 2014
Last Update Posted : December 3, 2014
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 and patient outcomes related to the above clinical trials.
|Condition or disease||Intervention/treatment||Phase|
|Spontaneous Bacterial Peritonitis||Drug: Dextran 70 Biological: human albumin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: 1: Dextran 70
antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three
Drug: Dextran 70
dextran 70, 1.0 g/kg on days one, two and three
Active Comparator: 2: Standard of Care Human Albumin
antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
Biological: human albumin
human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
- 30 Day All Cause Mortality [ Time Frame: 30 days ]30 day all cause mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570960
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Patrick G Northup, M.D.||University of Virginia|