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Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ALBUMIN
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cirrhosis focused on measuring Cirrhosis, hepatitis B virus, Alcohol, varices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of SBP
  2. Age > 18 years
  3. Consent to participate in the trial

Exclusion Criteria:

  1. Secondary peritonitis
  2. Malignancies including HCC

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    STANDARD DOSE

    LOW DOSE

    Arm Description

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

    Albumin 20g/d for 5 days

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Survival in days at the end of therapy
    Differences in frequency of sepsis, renal failure and other organ failures between the two groups

    Full Information

    First Posted
    April 24, 2016
    Last Updated
    April 27, 2016
    Sponsor
    All India Institute of Medical Sciences, New Delhi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02756741
    Brief Title
    Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis
    Official Title
    Assessment of Cytokine Profile in an Open Labeled Randomized Controlled Trial of Standard Dose vs. Once a Day Intravenous Albumin in Patients With Spontaneous Bacterial Peritonitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    All India Institute of Medical Sciences, New Delhi

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cirrhosis
    Keywords
    Cirrhosis, hepatitis B virus, Alcohol, varices

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    STANDARD DOSE
    Arm Type
    Active Comparator
    Arm Description
    Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3
    Arm Title
    LOW DOSE
    Arm Type
    Placebo Comparator
    Arm Description
    Albumin 20g/d for 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    ALBUMIN
    Intervention Description
    Albumin in two different doses
    Primary Outcome Measure Information:
    Title
    Change in neutrophils/mm in ascitic fluid
    Time Frame
    3 days
    Title
    Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    Survival in days at the end of therapy
    Time Frame
    5 days
    Title
    Differences in frequency of sepsis, renal failure and other organ failures between the two groups
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of SBP Age > 18 years Consent to participate in the trial Exclusion Criteria: Secondary peritonitis Malignancies including HCC

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

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