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

NCT ID: NCT02756741

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis

Keywords

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Cirrhosis hepatitis B virus Alcohol varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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STANDARD DOSE

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

Group Type ACTIVE_COMPARATOR

ALBUMIN

Intervention Type DRUG

Albumin in two different doses

LOW DOSE

Albumin 20g/d for 5 days

Group Type PLACEBO_COMPARATOR

ALBUMIN

Intervention Type DRUG

Albumin in two different doses

Interventions

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ALBUMIN

Albumin in two different doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Subrat Kumar Acharya

Professor and Head, Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AIIMS sbp

Identifier Type: -

Identifier Source: org_study_id