Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis
- Registration Number
- NCT02756741
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Diagnosis of SBP
- Age > 18 years
- Consent to participate in the trial
Exclusion Criteria
- Secondary peritonitis
- Malignancies including HCC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LOW DOSE ALBUMIN Albumin 20g/d for 5 days STANDARD DOSE ALBUMIN Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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