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

NCT00570960 | Terminated Phase 4 Results DMC

• 1 other identifier: 13104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 4.Establish a comprehensive tissue bank of blood, ascites, and urine in patients with spontaneous bacterial peritonitis for future testing and translational research.
5. 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.

Conditions

Spontaneous Bacterial Peritonitis

Keywords

Peritonitis

Outcome Measures

Primary Outcomes (1)

• 30 Day All Cause Mortality

  30 day all cause mortality

  30 days

Study Arms (2)

1: Dextran 70

EXPERIMENTAL

antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three

Drug: Dextran 70

2: Standard of Care Human Albumin

ACTIVE COMPARATOR

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

Interventions

Dextran 70 DRUG

dextran 70, 1.0 g/kg on days one, two and three

1: Dextran 70

human albumin BIOLOGICAL

human albumin 1.5 g/kg on day one and 1.0 g/kg on day three

2: Standard of Care Human Albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• American Association for the Study of Liver Diseases: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Peritonitis

Interventions

Dextrans; Serum Albumin, Human

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Limitations and Caveats

The study was terminated early because the manufacturer of Dextran 70 ceased all production of the study drug approximately 10 months into the study. It was felt by the principle investigator that continuation of the study was impossible.

Results Point of Contact

• Title: Patrick G. Northup, M.D.
• Organization: University of Virginia

northup@virginia.edu

434-924-0000

Study Officials

• Patrick G Northup, M.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 3, 2014
• Results First Posted: December 3, 2014

Record last verified: 2014-12

Locations

US (1)