NCT00761098

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2011

Enrollment Period

5 years

First QC Date

September 25, 2008

Last Update Submit

January 3, 2011

Conditions

Spontaneous Bacterial PeritonitisCirrhosis

Keywords

CirrhosisSBP

Outcome Measures

Primary Outcomes (1)

  • Renal Failure

    Duration of Hospital Admission

Secondary Outcomes (2)

  • All Cause Mortality

    Duration of Hospital Admission

  • Albumin Utilization

    Duration of Hospital Admission

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Standard Care

2

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.

Drug: Experimental

Interventions

Standard CareDRUG

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

1
ExperimentalDRUG

25% Salt Poor 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.

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75
  • End Stage Liver Disease / Cirrhosis
  • Documented SBP (ANC \> 250 or positive ascites culture)
  • Ability to provide informed consent
  • Serum Creatinine \> 1.0 and/or Total Bilirubin \> 4.0

You may not qualify if:

  • Nonportal hypertensive ascites (i.e. malignancy)
  • Hepatic Encephalopathy precluding informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York Presbyterian Hospital - Weill Cornell Medical Center

New York, New York, 10021, United States

RECRUITING

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

  • Sort P, Navasa M, Arroyo V, Aldeguer X, Planas R, Ruiz-del-Arbol L, Castells L, Vargas V, Soriano G, Guevara M, Gines P, Rodes J. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. N Engl J Med. 1999 Aug 5;341(6):403-9. doi: 10.1056/NEJM199908053410603.

    PMID: 10432325BACKGROUND

MeSH Terms

Conditions

Fibrosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Samuel H Sigal, MD

    New York Presbyterian Hospital - Cornell/Columbia

    PRINCIPAL INVESTIGATOR

  • Ilan S Weisberg, MD

    New York Presbyterian Hospital - Cornell/Columbia

    STUDY DIRECTOR

Central Study Contacts

Samuel H Sigal, MD

CONTACT

646-962-5483shs2015@med.cornell.edu

Ilan S Weisberg, MD

CONTACT

646-962-4800iw2104@columbia.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

May 1, 2005

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

January 4, 2011

Record last verified: 2011-01

Locations

US(2)