LandmarkRCT

Sort et al.

Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis

New England Journal of Medicine, 1999 · Randomized controlled trial

Clinical question

Does plasma volume expansion with intravenous albumin, added to antibiotic treatment, prevent renal impairment and death in cirrhosis with spontaneous bacterial peritonitis?

Population: 126 patients with cirrhosis and spontaneous bacterial peritonitis.
Intervention: Intravenous cefotaxime plus intravenous albumin 1.5 g/kg at diagnosis, followed by 1 g/kg on day 3 (63 patients).
Comparator: Intravenous cefotaxime alone (63 patients).
Primary outcome: Renal impairment (nonreversible deterioration of renal function during hospitalization) and mortality.
Secondary outcomes: Resolution of the infection.
Plasma renin activity.
Three-month mortality.
Result: Adding albumin to the antibiotic did not change infection resolution but reduced renal impairment and death. (Renal impairment 33% vs 10%; in-hospital death 29% vs 10%; three-month mortality 41% vs 22%., p = 0.002 for renal impairment; p = 0.01 for in-hospital death; p = 0.03 for three-month mortality)

What the trial found

Infection resolved in 94% on cefotaxime alone and 98% on cefotaxime plus albumin (not significant). Renal impairment developed in 33% vs 10%, in-hospital death occurred in 29% vs 10%, and three-month mortality was 41% vs 22%, all favoring albumin. Patients treated without albumin had higher plasma renin activity.

Current guideline position

AASLD 2021 guidance in this library supports appropriate albumin use in SBP. Guidelines differ on whether the full regimen is given to every patient or reserved for higher-risk patients.

Clinical interpretation

The trial is the basis for giving intravenous albumin with antibiotics in SBP to protect the kidneys by supporting effective arterial volume. It also underpins the later logic of recognizing and treating HRS-AKI early in cirrhosis with infection.

Limitations

Relatively small trial (126 patients), conducted when cefotaxime was the standard antibiotic.
Later guidelines have debated which patients benefit most, since the high-risk subgroup carries much of the effect.

Moderate certainty

Clinical Context & Relevant Topics (2)

Disease Reference

Decompensated Cirrhosis & ACLF

Recognition and organ-support of decompensated cirrhosis and acute-on-chronic liver failure, including bleeding, infection, encephalopathy and transplant triage

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Hepatorenal Syndrome–AKI

Diagnosis and ICU management of HRS-AKI with albumin, vasoconstrictors, respiratory-safety monitoring, RRT and transplant planning

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