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Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis (SBP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00761098
First received: September 25, 2008
Last updated: January 3, 2011
Last verified: January 2011
  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.


Condition Intervention Phase
Spontaneous Bacterial Peritonitis
Cirrhosis
Drug: Standard Care
Drug: Experimental
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Renal Failure [ Time Frame: Duration of Hospital Admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Cause Mortality [ Time Frame: Duration of Hospital Admission ] [ Designated as safety issue: No ]
  • Albumin Utilization [ Time Frame: Duration of Hospital Admission ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2005
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard Care (albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
Drug: Standard Care
Standard Care: 25% salt poor 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.
Drug: 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.

Detailed Description:

Spontaneous bacterial peritonitis (SBP), infection of the peritoneal fluid(ascites) without evidence of a surgically treatable source, is a common and frequently fatal complication of patients with endstage hepatic cirrhosis. It originates with the passage of bacteria from the intestinal lumen to the systemic circulation and then to the ascitic fluid. Early diagnosis with paracentesis (aspiration of an ascites fluid sample to assess for evidence of infection) and the development of nonnephrotoxic third generation cephalosporin antibiotics have decreased the in hospital mortality from nearly 100% to approximately 30%. Mortality in patients with SBP is invariably associated with the development of functional renal failure. Recently, the administration of two large doses of human serum albumin at diagnosis and at 72 hours has been reported to further reduce mortality and renal failure to 10%. These findings have lead to the recommendation that patients with SBP be treated with albumin. However, no study has evaluated the necessary amount and timing of albumin administration required for its beneficial action.

In this study we 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.

80 consecutive patients with cirrhosis and SBP who are at risk for renal failure will be enrolled at either the Columbia University Medical Center or The New York Hospital Weill Cornell Medical Center. Baseline clinical and biochemical data will be obtained for etiology and severity of liver disease. All patients will receive antibiotics and salt poor albumin at 1.5g/kg at time of diagnosis and diuretics discontinued (current standard of care). Patients will be randomized to receive the second dose (1.0 gm/kg) at 72 hours (group 1, standard of care) or at 48 hours only if renal function remains elevated after two days of therapy (Group 2). For the latter group of patients, albumin will be administered if the Cr is > 1.0 mg/dl or if the BUN or creatinine levels are higher than admission levels at 48 hours. If albumin is not administered at 48 hours, renal function will be monitored daily, and it will be administered should the BUN or creatinine increase to levels greater than those on admission. Renal failure rates, duration of transient azotemia, mortality, and albumin utilization rated will be compared between the groups who receive albumin in the usual manner at 72 hours versus those who receive it at 48 hours based on renal function.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761098

Contacts
Contact: Samuel H Sigal, MD 646-962-5483 shs2015@med.cornell.edu
Contact: Ilan S Weisberg, MD 646-962-4800 iw2104@columbia.edu

Locations
United States, New York
New York Presbyterian Hospital - Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Samuel H Sigal, MD    212-305-9140    shs2015@med.cornell.edu   
Contact: Ilan S Weisberg, MD    212-305-9140    iw2104@columbia.edu   
Principal Investigator: Samuel H Sigal, MD         
Sub-Investigator: Ilan S Weisberg, MD         
Sub-Investigator: Reem Sharaiha, MD         
Sub-Investigator: Brian Kim, MD         
Sub-Investigator: Robert Brown, MD, MPH         
Sub-Investigator: Lorna Dove, MD, MPH         
Sub-Investigator: Scott Fink, MD         
New York Presbyterian Hospital - Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Samuel H Sigal, MD    646-962-5483    shs2015@med.cornell.edu   
Contact: Ilan S Weisberg, MD    646-962-4800    iw2104@columbia.edu   
Principal Investigator: Samuel H Sigal, MD         
Sub-Investigator: Ilan S Weisberg, MD         
Sub-Investigator: Arun Jesudian, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Samuel H Sigal, MD New York Presbyterian Hospital - Cornell/Columbia
Study Director: Ilan S Weisberg, MD New York Presbyterian Hospital - Cornell/Columbia
  More Information

Publications:
Responsible Party: Samuel Sigal, MD, Weill Cornell Medical Center / Columbia Prebyterian Medical Center
ClinicalTrials.gov Identifier: NCT00761098     History of Changes
Other Study ID Numbers: #0410007526/1104-564
Study First Received: September 25, 2008
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Cirrhosis
SBP

Additional relevant MeSH terms:
Peritonitis
Digestive System Diseases
Infection
Intraabdominal Infections
Peritoneal Diseases

ClinicalTrials.gov processed this record on November 20, 2014