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NCT00570960 · ClinicalTrials.gov registry record · Phase 4
Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
A Phase 4 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT00570960 is a Phase 4 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 8 participants.
The verdict
NCT00570960, a Phase 4 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- DRUG Dextran 70
- BIOLOGICAL human albumin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-06 |
| Est. Completion | 2010-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00570960
The ClinicalTrials.gov registry entry for NCT00570960 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dextran 70 is the first listed.
NCT00570960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00570960 about?
NCT00570960 is a clinical study titled "Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis". 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 ...
What is the current status of trial NCT00570960?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2007-06. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00570960?
The interventions under investigation include: Dextran 70 (DRUG), human albumin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00570960?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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