Recruiting

Albumin

Sponsor:

Weill Medical College of Cornell University

Code:

NCT00761098

Conditions

Spontaneous Bacterial Peritonitis

Cirrhosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard Care

Experimental

Study Details

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.

Conditions

Spontaneous Bacterial Peritonitis

Cirrhosis

Study ID

NCT00761098

Start date

May, 2005

Status verified date

Jan, 2011

Completion date

Aug, 2010

Anticipated

Primary completion date

May, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

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

experimental: 2

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.

Interventions

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 only to those individuals with renal insufficiency and risk for renal failure.

Primary outcome measure

  • Renal Failure [ Time Frame: Duration of Hospital Admission ]

Central Contacts and Locations

Central contacts

Samuel H Sigal, MD

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

Ilan S Weisberg, MD

646-962-4800iw2104@columbia.edu

Locations

New York Presbyterian Hospital - Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Samuel H Sigal, MD

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

Ilan S Weisberg, MD

646-962-4800iw2104@columbia.edu

Principal Investigator:

Samuel H Sigal, MD

New York Presbyterian Hospital - Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Samuel H Sigal, MD

212-305-9140shs2015@med.cornell.edu

Ilan S Weisberg, MD

212-305-9140iw2104@columbia.edu

Principal Investigator:

Samuel H Sigal, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jan 4, 2011

Last verified

Jan, 2011

Keywords

  • Cirrhosis
  • SBP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2011-01-04.