Sort P. NEJM 1999; 341(6): 403-9.
RESULTS
Randomization: 199 consecutive patients with cirrhosis who had spontaneous bacterial peritonitis, 73 excluded, 126 randomized.
Baseline: Average age 62y, 30% had alcoholic cirrhosis, 11% had hepatocellular carcinoma, average Child-Pugh score was 10.2, 44% had renal failure, 65% on diuretic therapy, 57% had isolated organism, most being E. coli.
Outcomes:
Resolution of infection: 98 vs 94%, p = 0.36
Renal impairment: 10 vs 33%, ARR 23%, NNT 4.3, p = 0.002
Death, in hospital: 10 vs 29%, ARR 19%, NNT 5.3, p = 0.01
Death, at three months: 22 vs 41%, ARR 19%, NNT 5.3, p = 0.03
Adverse Events: no reported adverse events
Discussion: Cost of albumin is between $5 and $25 per gram in the US. For the average 70kg man, this would cost between $875 to $4,375 per patient, and $4,375 to $23,200 to save one life. Mortality rates from SBP have been steadily decreasing over the last 15 years, this serves as another tool for prevention of hepatorenal syndrome and death.
METHODS
Sponsors: Grants from the Fondo de Investigacion Sanitaria (FIS) and the Hospital Clinic
Study Type: open-label, randomized control trial, seven university hospitals.
Time Frame: November 1995 to September 1997
Inclusion: PMN > 250 cells/mm3, age 18 to 80y
Exclusion: (1) Antibiotic treatment within 1 week of dx, (2) shock, (3) GI bleeding, (4) ileus, (5) grade 3 or 4 hepatic encephalopathy, (6) cardiac failure, (7) findings suggestive of organic nephropathy, (8) HIV, (9) any disease that could affect short-term prognosis, and (10) serum creatinine < 3.0 mgdL
Treatment: Creatinine clearance adjusted dose cefotaxime and (1) albumin 1.5g/kg IV in the first 6 hours, and then 1.0 g/kg on day 3 vs (2) antibiotic alone.
Outcomes: (1) Resolution of infection, (2) duration of antibiotic therapy, (3) hospital stay, (4) renal impairment, (5) death, in hospital, (6) and death at three months.
ADDITIONAL READING
Gines P. Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis. Gastroenterology 1988; 94: 1493-1502.
Luca A. Beneficial effects of intravenous albumin infusion on hemodynamic and humoral changes after total paracentesis. Hepatology 1995; 22: 753-58.
Gines A. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by parecentesis. Gastroenterology 1996; 111: 1002 - 10.
Castellote J. Rapid diagnosis of spontaneous bacterial peritonitis by use of reagent strips. Hepatology 2003 Apr; 37(4): 893-6.
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