NCT02756741

Brief Summary

The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Status
completed

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

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 24, 2016

Last Update Submit

April 27, 2016

Conditions

Cirrhosis

Keywords

Cirrhosishepatitis B virusAlcoholvarices

Outcome Measures

Primary Outcomes (2)

  • Change in neutrophils/mm in ascitic fluid

    3 days

  • Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups

    5 days

Secondary Outcomes (2)

  • Survival in days at the end of therapy

    5 days

  • Differences in frequency of sepsis, renal failure and other organ failures between the two groups

    5 days

Study Arms (2)

STANDARD DOSE

ACTIVE COMPARATOR

Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3

Drug: ALBUMIN

LOW DOSE

PLACEBO COMPARATOR

Albumin 20g/d for 5 days

Drug: ALBUMIN

Interventions

ALBUMINDRUG

Albumin in two different doses

LOW DOSESTANDARD DOSE

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of SBP
  • Age \> 18 years
  • Consent to participate in the trial

You may not qualify if:

  • Secondary peritonitis
  • Malignancies including HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FibrosisHepatitis BVaricose Veins

Interventions

Albumins

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head, Department of Gastroenterology

Study Record Dates

First Submitted

April 24, 2016

First Posted

April 29, 2016

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 29, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share