Respiratory Trials·org

Gastroenterology in critical care · Albumin in spontaneous bacterial peritonitis

Sort 1999 randomised trial

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.

  • Less renal impairment with albumin
  • Lower in-hospital and three-month mortality
  • No difference in resolution of infection