Expired Study
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New York, New York 10016


Purpose:

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.


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)


Study is Available At:


Original ID:

10-00743


NCT ID:

NCT02528097


Secondary ID:


Study Acronym:


Brief Title:

A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

2


Enrollment Type:

Actual


Overall Contact Information

Official Name:Samuel Sigal
Principal Investigator
NYU MEDICAL CENTER

Study Dates

Start Date:September 2010
Completion Date:January 2015
Completion Type:Actual
Primary Completion Date:January 2015
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:August 18, 2015
First Received Date:April 4, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:All Cause Mortality
Time Frame:At any point from time 0 through day 3
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Renal Failure
Time Frame:At any point from time 0 through day 3
Safety Issues:False
Description:Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours

Study Interventions

Intervention Type:Drug
Name:Standard Care
Description:Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Arm Name:Active Comparator Standard Care
Intervention Type:Drug
Name:Experimental
Description: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)
Arm Name:Experimental

Study Arms

Study Arm Type:Experimental
Arm Name:Experimental
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.
Study Arm Type:Placebo Comparator
Arm Name:Active Comparator Standard Care
Description:albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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