A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

NCT ID: NCT02528097

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Comparator Standard Care

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

Group Type: PLACEBO_COMPARATOR

Standard Care

Intervention Type: DRUG

Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)

Experimental

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.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DRUG

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)

Interventions

Standard Care

Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)

Intervention Type: DRUG

Experimental

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)

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Sigal

Role: PRINCIPAL_INVESTIGATOR

NYU MEDICAL CENTER

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

10-00743

Identifier Type: -

Identifier Source: org_study_id