Effect of intravenous albumin on renal impairment and mortality in cirrhosis and spontaneous bacterial peritonitis
Sort 1999 trial design and results
Design
Randomised controlled trial
Treatment
Cefotaxime plus intravenous albumin 1.5 g/kg at diagnosis, then 1 g/kg on day 3
Control
Cefotaxime alone
Population
126 patients with cirrhosis and spontaneous bacterial peritonitis
Follow-up
3 months
Primary endpoint
Renal impairment and mortality
Result
Infection resolved in 59 of 63 (94%) with cefotaxime and 62 of 63 (98%) with cefotaxime plus albumin (p=0.36). Renal impairment developed in 21 (33%) versus 6 (10%), p=0.002. In-hospital mortality was 29% versus 10% (p=0.01) and three-month mortality 41% versus 22% (p=0.03).
Secondary endpoints
In-hospital mortality, three-month mortality, resolution of infection
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.
The trial authors, in the published abstract
How it has aged
Standard care ever since, and one of the clearest indications for albumin anywhere in medicine — a striking exception in a fluid whose broader use has repeatedly failed to show benefit.
Publications
Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis
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.