Cirrhosis
Conditions
Keywords
Cirrhosis, hepatitis B virus, Alcohol, varices
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.
Interventions
DRUGALBUMIN
Albumin in two different doses
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed