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

Sponsor

All India Institute of Medical Sciences, New Delhi (Other)

Overall Status

Completed

CT.gov ID

NCT02756741

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis	Drug: ALBUMIN	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: STANDARD DOSE Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3	Drug: ALBUMIN Albumin in two different doses
Placebo Comparator: LOW DOSE Albumin 20g/d for 5 days	Drug: ALBUMIN Albumin in two different doses

Arm

Intervention/Treatment

Active Comparator: STANDARD DOSE

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

Drug: ALBUMIN

Albumin in two different doses

Placebo Comparator: LOW DOSE

Albumin 20g/d for 5 days

Drug: ALBUMIN

Albumin in two different doses

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Secondary peritonitis
Malignancies including HCC

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Subrat Kumar Acharya, Professor and Head, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

ClinicalTrials.gov Identifier:

NCT02756741

Other Study ID Numbers:

AIIMS sbp

First Posted:

Apr 29, 2016

Last Update Posted:

Apr 29, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Subrat Kumar Acharya, Professor and Head, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

Additional relevant MeSH terms:

Peritonitis

Fibrosis

Study Results

No Results Posted as of Apr 29, 2016