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Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis

This study has been terminated.
(drug product became unavilable)
Sponsor:
Collaborator:
American Association for the Study of Liver Diseases
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00570960
First received: December 10, 2007
Last updated: June 23, 2010
Last verified: June 2010
History of Changes
  Purpose

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.

Condition Intervention Phase
Spontaneous Bacterial Peritonitis
 Drug: Dextran 70
Biological: human albumin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite endpoint of 30 day survival, survival to liver transplantation, prevention of the hepatorenal syndrome, and resolution of clinical infection [ Time Frame: 30 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: June 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets all criteria for SBP as outlined below:

    • Ascites fluid analysis showing greater than or equal to 250 PMN permm3 as reported by automated or manual differential cell count
    • Lack of source of secondary peritonitis (e.g. appendicitis, acute cholecystitis)
    • Lack of a ruptured hollow viscous resulting in peritoneal soilage with multiple organisms
  • Age > 18
  • No antibiotic treatment within seven days prior to the diagnosis of SBP (except routine prophylaxis for SBP or initial empiric antibiotics at the time of diagnosis)
  • Absence of other clinical infections
  • Lack of any other systemic disease that could limit lifespan to less than 90 days
  • Serum creatinine <3.0 mg/dL or calculated GFR>15 ml/min
  • Serum international normalized ratio (INR)<3.0

Exclusion Criteria:

  • Known hypersensitivity to a component of either of the study drugs
  • Unwillingness to undergo diagnostic paracentesis
  • Inability or unwillingness to give informed consent for study participation
  • Shock or hemodynamic instability
  • Active, clinically evident gastrointestinal bleeding, excluding heme-positive stools only
  • Active congestive heart failure or inability to tolerate fluid volumes of study drugs
  • Uncontrolled diabetes mellitus or hyperglycemia >400 mg/dl at screening
  • Evidence for organic nephropathy, e.g. proteinuria >2+ on spot urine, hematuria>15 RBC's per HPF, abnormality on renal ultrasound
  • Clinical history of severe volume depletion (i.e. severe diarrhea or brisk response to diuretics) within one week of diagnosis of SBP
  • Laparotomy within the past 30 days prior to diagnosis of SBP
  • Peritoneovenous shunt in place (i.e. Denver or LaVeen shunt)
  • Prison inmate or resident of psychiatric facility
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570960

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
American Association for the Study of Liver Diseases
Investigators
Principal Investigator: Patrick G Northup, M.D. University of Virginia
  More Information

No publications provided

Responsible Party: Patrick G. Northup, University of Virginia
ClinicalTrials.gov Identifier: NCT00570960     History of Changes
Other Study ID Numbers: 13104
Study First Received: December 10, 2007
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Peritonitis

Additional relevant MeSH terms:
Peritonitis
Peritoneal Diseases
Digestive System Diseases
Dextrans
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on May 16, 2013