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Sponsored by: |
University of Virginia |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00570960 |
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:
Condition | Intervention | Phase |
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Spontaneous Bacterial Peritonitis |
Drug: Dextran 70 Biological: human albumin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis |
Estimated Enrollment: | 116 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three
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Drug: Dextran 70
dextran 70, 1.0 g/kg on days one, two and three
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2: Active Comparator
antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three
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Biological: human albumin
human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meets all criteria for SBP as outlined below:
Exclusion Criteria:
Contact: Patrick Northup, M.D. | 434-243-2718 | pgn5qs@virginia.edu |
Contact: Elizabeth Tarkington, RN | 434-982-0871 | ehty9y@virginia.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Patrick G Northup, M.D. 434-243-2718 pgn5qs@virginia.edu | |
Contact: Elizabeth Tarkington, RN 434-982-0871 | |
Principal Investigator: Partick Northup, MD |
Principal Investigator: | Patrick G Northup, M.D. | University of Virginia |
Responsible Party: | University of Virginia ( Patrick G. Northup ) |
Study ID Numbers: | 13104 |
Study First Received: | December 10, 2007 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00570960 |
Health Authority: | United States: Institutional Review Board |
Peritonitis |
Digestive System Diseases Peritonitis Peritoneal Diseases Dextrans |
Anticoagulants Therapeutic Uses Blood Substitutes |
Hematologic Agents Plasma Substitutes Pharmacologic Actions |