Sort SBP albumin trial
Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis
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Overview
In cirrhosis with SBP, IV albumin plus cefotaxime reduced in-hospital renal impairment and death compared with cefotaxime alone.
Clinical takeaway
When treating spontaneous bacterial peritonitis, add intravenous albumin to antibiotic therapy. Infection clearance was similar; the difference was less renal impairment and lower death.
Key result
Renal impairment occurred in 10% with cefotaxime plus albumin versus 33% with cefotaxime alone (P=0.002); in-hospital death was 10% versus 29% (P=0.01).
Practice impact
Give IV albumin with antibiotics for SBP in cirrhosis, using 1.5 g/kg at diagnosis and 1 g/kg on day 3.
Evidence
Study design
Randomized trial comparing intravenous cefotaxime alone with cefotaxime plus intravenous albumin.
Enrollment
126
Follow-up
In-hospital renal impairment and death, with mortality also reported at 3 months.
Geography
Not listed
Clinical question
Does intravenous albumin added to cefotaxime prevent renal impairment and reduce death in cirrhosis with spontaneous bacterial peritonitis?
Population
- 126 patients with cirrhosis and spontaneous bacterial peritonitis (63 assigned to each arm).
Intervention
Cefotaxime plus intravenous albumin 1.5 g per kilogram of body weight at diagnosis, then 1 g per kilogram on day 3. Cefotaxime dose varied with serum creatinine.
Comparator
Intravenous cefotaxime alone, dosed according to the serum creatinine level.
Primary outcome
Lead reported outcomes (the abstract does not label a primary end point): renal impairment, defined as nonreversible deterioration of renal function during hospitalization, and mortality.
Renal impairment was less common with cefotaxime plus albumin than with cefotaxime alone (10% vs 33%; P=0.002). In-hospital death was also lower (10% vs 29%; P=0.01). No effect estimate or confidence interval was reported.
p=0.002
Key results
- Renal impairment developed in 6 of 63 patients (10%) with cefotaxime plus albumin versus 21 of 63 (33%) with cefotaxime alone (P=0.002).
- In-hospital death occurred in 6 patients (10%) with cefotaxime plus albumin versus 18 (29%) with cefotaxime alone (P=0.01).
- At 3 months, mortality was 22% (14 deaths) with albumin versus 41% (26 deaths) without albumin (P=0.03).
- Infection resolved in 62 patients (98%) with albumin versus 59 (94%) without albumin (P=0.36). Plasma renin activity was higher without albumin, especially among patients who developed renal impairment.
Harms
Not listed.
Clinical Use
Practice impact
- Add intravenous albumin to antibiotics when treating SBP in cirrhosis, at 1.5 g/kg at diagnosis and 1 g/kg on day 3.
Applicability
- Most applicable to patients with cirrhosis and spontaneous bacterial peritonitis treated with cefotaxime.
Limitations
- No relative risk, odds ratio, or confidence interval was reported for renal impairment or death.
- Renal impairment was defined only as nonreversible deterioration of renal function during hospitalization.
- The trial randomized 126 patients and does not describe blinding.
Common misinterpretations
- This is not a trial of albumin for all cirrhosis complications; the population had spontaneous bacterial peritonitis.
- Infection resolution was similar between arms, so the result is not about clearing the infection.
Related evidence
Citation
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;341(6):403-409. doi:10.1056/NEJM199908053410603
In patients with cirrhosis and spontaneous bacterial peritonitis, treatment with intravenous albumin in addition to an antibiotic reduces the incidence of renal impairment and death in comparison with treatment with an antibiotic alone.
- PMID
- 10432325