Albumin for SBP
Trial question
Is antibiotics plus intravenous albumin superior to antibiotics alone in patients with cirrhosis and SBP?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 126
126 patients (45 female, 81 male)
Inclusion criteria: patients with cirrhosis and SBP
Key exclusion criteria: treatment with antibiotics, gastrointestinal bleeding, organic nephropathy, a serum creatinine level > 3 mg/dL, cardiac failure, age > 80 years, septic shock, or dehydration
Interventions
N=63 cefotaxime and albumin (cefotaxime daily, dosage varied according to the serum creatinine level, and albumin given at a dose of 1.5 g/kg of body weight at the time of diagnosis, followed by 1 g/kg on day 3)
N=63 cefotaxime alone (daily dosage varied according to the serum creatinine level)
Primary outcome
Renal impairment
10
33
33.0 %
24.8 %
16.5 %
8.3 %
0.0 %
Cefotaxime and albumin
Cefotaxime alone
Significant decrease ▼
NNT = 4
Significant decrease in renal impairment (10% vs. 33%; RR 0.3, 95% CI 0.11 to 0.49)
Secondary outcomes
Significant decrease in in-hospital death (10% vs. 29%; RR 0.34, 95% CI 0.08 to 0.6)
Safety outcomes
No significant difference in rate of adverse events.
Conclusion
In patients with cirrhosis and SBP, cefotaxime and albumin were superior to cefotaxime alone with respect to renal impairment.
Reference
Sort P, Navasa M, Arroyo V et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. N Engl J Med. 1999 Aug 5;341(6):403-9.
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