A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Study Overview
=================
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.

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

Conditions
-----------------
Spontaneous Bacterial Peritonitis

Intervention / Treatment
-----------------
* Drug: Standard Care
* Drug: Experimental


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Active Comparator Standard Care<br>albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) | Drug: Standard Care<br>* Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)<br>|
| Experimental: Experimental<br>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. | Drug: Experimental<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Failure | Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours | At any point from time 0 through day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality |  | At any point from time 0 through day 3 |