A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

NYU Langone Health

Status: Terminated

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Experimental; Drug: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02528097

10-00743

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups, including a placebo group

Active Comparator Standard Care

Placebo Comparator group

Description:

albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)

Treatment:

Drug: Standard Care

Experimental

Experimental group

Description:

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.

Treatment:

Drug: Experimental