Clinical, Inflammatory, and Economic Impact of Dextran 70 in Treating Spontaneous Bacterial Peritonitis
Condition: Spontaneous Bacterial Peritonitis
MeSH terms: Peritonitis
Intervention: Dextran 70; human albumin
Intervention description: dextran 70, 1.0 g/kg on days one, two and three; human albumin 1.5 g/kg on day one and 1.0 g/kg on day three
Intervention MeSH terms: Dextrans
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peritonitis

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.
    

Eligibility 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