A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02528097
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 52
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Bacterial Peritonitis	Drug: Standard Care; Drug: Experimental	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Active Comparator 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: 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; 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)

Outcome Measures

Primary Outcome Measures

1. Renal Failure [At any point from time 0 through day 3]

   Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours

Secondary Outcome Measures

1. All Cause Mortality [At any point from time 0 through day 3]

Other Outcome Measures

1. Administration of Albumin [Throughout Study (72 hours)]

   The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Samuel Sigal, NYU MEDICAL CENTER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02528097
• Other Study ID Numbers: 10-00743
• First Posted: Aug 19, 2015
• Last Update Posted: Jul 11, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Peritonitis

Study Results

Participant Flow

Arm/Group Title	Active Comparator Standard Care	Experimental
Arm/Group Description	albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)	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. Experimental: 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)
Period Title: Overall Study
STARTED	1	1
COMPLETED	1	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Active Comparator Standard Care	Experimental	Total
Arm/Group Description	albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)	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. Experimental: 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)	Total of all reporting groups
Overall Participants	1	1	2
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 100%	1 100%	2 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	1 100%	1 50%
Male	1 100%	0 0%	1 50%

Outcome Measures

1. Primary Outcome

Title	Renal Failure
Description	Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours
Time Frame	At any point from time 0 through day 3

Outcome Measure Data

Analysis Population Description

Outcome data was not collected due to logistical challenges of completing the study.

Arm/Group Title	Active Comparator Standard Care	Experimental
Arm/Group Description	albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)	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. Experimental: 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)
Measure Participants	0	0

2. Secondary Outcome

Title	All Cause Mortality
Time Frame	At any point from time 0 through day 3

Outcome Measure Data

Analysis Population Description

Outcome data was not collected due to logistical challenges of completing the study.

Arm/Group Title	Active Comparator Standard Care	Experimental
Arm/Group Description	albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)	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. Experimental: 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)
Measure Participants	0	0

3. Other Pre-specified Outcome

Title	Administration of Albumin
Description	The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)
Time Frame	Throughout Study (72 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Active Comparator Standard Care		Experimental
Arm/Group Description	albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg) Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)		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. Experimental: 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)
All Cause Mortality
	Active Comparator Standard Care		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Active Comparator Standard Care		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Active Comparator Standard Care		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.