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

Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756741
• Other study ID #: AIIMS sbp
• Status: Completed
• Phase: N/A
• First received: April 24, 2016
• Last updated: April 27, 2016
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2016
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethical committee AIIMS New Delhi : India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cirrhosis
• Peritonitis

Intervention

Drug:
• ALBUMIN
Albumin in two different doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neutrophils/mm in ascitic fluid		3 days	No
Primary	Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups		5 days	No
Secondary	Survival in days at the end of therapy		5 days	No
Secondary	Differences in frequency of sepsis, renal failure and other organ failures between the two groups		5 days	No