A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528097
• Other study ID #: 10-00743
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: August 18, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: August 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Administration of albumin	The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)	Throughout Study (72 hours)	No
Primary	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	No
Secondary	All Cause Mortality		At any point from time 0 through day 3	No