A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

A Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

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.

Albumin 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.

25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)

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

The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)

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 Exclusion Criteria: Nonportal hypertensive ascites (i.e. malignancy)