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A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Not Applicable
Terminated
Conditions
Spontaneous Bacterial Peritonitis
Interventions
Drug: Standard Care
Drug: Experimental
Registration Number
NCT02528097
Lead Sponsor
NYU Langone Health
Brief Summary

Spontaneous bacterial peritonitis (SBP) is a common and frequently fatal complication of end-stage liver disease with a mortality of up to 10% primarily due to the development of kidney failure. Current standard practice is to treat this infection with broad spectrum antibiotics and salt-poor albumin administration on day one and three of treatment. In this study the investigators test the hypothesis that the administration of a second dose of albumin at 48 hours only to patients with renal insufficiency is as effective at preventing kidney failure as administering the second dose to all patients at 72 hours. In addition, a kidney function determined approach to albumin dosing may lead to substantial cost and resource saving from decreased albumin use without compromising treatment efficacy.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
Inclusion Criteria
  • Age 18 to 75
  • Evidence of end stage liver disease / cirrhosis
  • Documented SBP (ANC > 250 or positive ascites culture
  • Ability to provide informed consent
  • Serum Creatinine > 1.0 mg/dL and/or Total Bilirubin > 4.0 mg/dL
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Exclusion Criteria
  • Nonportal hypertensive ascites (i.e. malignancy)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active Comparator Standard CareStandard Carealbumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
ExperimentalExperimentalAlbumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr \> 1.0 or BUN or Cr \> baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr \> 1.0 or BUN or Cr are above baseline.
Primary Outcome Measures
NameTimeMethod
Renal FailureAt any point from time 0 through day 3

Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours

Secondary Outcome Measures
NameTimeMethod
All Cause MortalityAt any point from time 0 through day 3

Trial Locations

Locations (1)

NYU Langone Medical Center

🇺🇸

New York, New York, United States

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