A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

NCT02528097 | Terminated Results DMC

• 1 other identifier: 10-00743
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• All Cause Mortality

  At any point from time 0 through day 3

Other Outcomes (1)

• Administration of Albumin

  Throughout Study (72 hours)

Study Arms (2)

Active Comparator Standard Care

PLACEBO COMPARATOR

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

Drug: Standard Care

Experimental

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.

Drug: Experimental

Interventions

Standard Care DRUG

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

Active Comparator Standard Care

Experimental 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)

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Nonportal hypertensive ascites (i.e. malignancy)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Due to the extremely small sample size, and the fact that the PI left the institution, no data was analyzed for this study

Results Point of Contact

• Title: The Office of Clinical Trials
• Organization: NYU Langone Medical Center

clinicaltrials@nyumc.org

646.754.7431

Study Officials

• Samuel Sigal

  NYU MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: August 19, 2015
• Study Start: September 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-05

Locations

US (1)