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

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ClinicalTrials.gov Identifier: NCT02756741
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in neutrophils/mm in ascitic fluid [ Time Frame: 3 days ]
  2. Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Survival in days at the end of therapy [ Time Frame: 5 days ]
  2. Differences in frequency of sepsis, renal failure and other organ failures between the two groups [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Subrat Kumar Acharya, Professor and Head, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02756741     History of Changes
Other Study ID Numbers: AIIMS sbp
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Subrat Kumar Acharya, All India Institute of Medical Sciences, New Delhi:
Cirrhosis
hepatitis B virus
Alcohol
varices
Additional relevant MeSH terms:
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Peritonitis
Fibrosis
Pathologic Processes
Digestive System Diseases
Intraabdominal Infections
Infection
Peritoneal Diseases