Albumin in cirrhotic patients with spontaneous bacterial peritonitis [Classics Series]

Classics Series, Landmark Trials in Medicine

1. In cirrhotic patients with spontaneous bacterial peritonitis, albumin infusion on days 1 and 3 of treatment in addition to antibiotics significantly reduces the risk of developing renal impairment and mortality when compared with antibiotics alone.

Original Date of Publication: August 5, 1999

Study Rundown: Renal impairment during spontaneous bacterial peritonitis (SBP) is a known risk factor for in-hospital mortality and is thought to be due to low effective circulating volume (ECV). This reduction in ECV is thought to be due to third-spacing, as well as excessive vasodilation resulting from systemic inflammatory response. Albumin is thought to increase the ECV by providing higher colloid pressures in the vasculature. This randomized, controlled study sought to determine the benefits of albumin in patients being treated for SBP. A total of 126 patients were randomized to receive antibiotics with albumin infusions, or albumin alone. In summary, patients treated with both antibiotics and albumin had significantly lower rates of renal impairment (10% vs. 33%, P=0.002) and mortality (in-hospital 10% vs. 29%, P=0.01; 3 months 22% vs. 41%, P=0.03) when compared to those receiving antibiotics alone.

Click to read the study in NEJM

In-Depth [randomized controlled trial]: This study involved 126 patients with cirrhosis who were diagnosed with SBP and randomized them to receive 1) antibiotics with albumin infusion or 2) antibiotics alone. Patients were recruited from 7 university hospitals in Spain. Patients in the albumin group received a 1.5 mg/kg dose of albumin on day 1 within 6 hours of enrollment in the study, and this was followed by a 1 mg/kg dose on day 3 of the study. All patients were treated with intravenous cefotaxime (dose-adjusted based on serum creatinine). After the resolution of infection, all patients were started on norfloxacin 400 mg daily prophylaxis. All investigators were blinded to treatment group assignment. Patients were included in the study if they had a polymorphonuclear cell count in the ascitic fluid >250/mm3, were between 18-80 years of age, had no antibiotic treatment within 1 week before the diagnosis of SBP (except for norfloxacin prophylaxis), did not have other infections/shock/gastrointestinal bleeding/ileus/grade 3 or 4 hepatic encephalopathy/organic nephropathy (i.e., proteinuria, hematuria, abnormal renal ultrasound), did not have human immunodeficiency virus infection, and had serum creatinine ≤265 μmol/L. Primary endpoints of the study were development of renal impairment (i.e., non-reversible deterioration of renal function during hospitalization) and mortality.

Patients receiving both antibiotics and albumin experienced significantly lower rates of renal impairment, when compared with patients being treated with antibiotics alone (10% vs. 33%, P=0.002). Moreover, patients in the antibiotics and albumin group experienced significantly lower mortality both in-hospital (10% vs. 29%, P=0.01) and at 3 months (22% vs. 41%, P=0.03), when compared with patients receiving antibiotics alone.

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