title: Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis.
abstract: OBJECTIVE
  Norfloxacin is highly effective in preventing spontaneous bacterial peritonitis recurrence in cirrhosis, but its role in the primary prevention of this complication is uncertain.
  
  
  METHODS
  Patients with cirrhosis and low protein ascitic levels (<15 g/L) with advanced liver failure (Child-Pugh score > or = 9 points with serum bilirubin level > or = 3 mg/dL) or impaired renal function (serum creatinine level > or = 1.2 mg/dL, blood urea nitrogen level > or = 25 mg/dL, or serum sodium level < or = 130 mEq/L) were included in a randomized controlled trial aimed at comparing norfloxacin (35 patients) vs placebo (33 patients) in the primary prophylaxis of spontaneous bacterial peritonitis. The main end points of the trial were 3-month and 1-year probability of survival. Secondary end points were 1-year probability of development of spontaneous bacterial peritonitis and hepatorenal syndrome.
  
  
  RESULTS
  Norfloxacin administration reduced the 1-year probability of developing spontaneous bacterial peritonitis (7% vs 61%, P < .001) and hepatorenal syndrome (28% vs 41%, P = .02), and improved the 3-month (94% vs 62%, P = .003) and the 1-year (60% vs 48%, P = .05) probability of survival compared with placebo.
  
  
  CONCLUSIONS
  Primary prophylaxis with norfloxacin has a great impact in the clinical course of patients with advanced cirrhosis. It reduces the incidence of spontaneous bacterial peritonitis, delays the development of hepatorenal syndrome, and improves survival.
authors.affiliation: Liver Unit, Hospital Clínic Barcelona, Barcelona, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Fernández
authors.forename: Miquel
authors.initials: M
authors.lastname: Navasa
authors.forename: Ramón
authors.initials: R
authors.lastname: Planas
authors.forename: Silvia
authors.initials: S
authors.lastname: Montoliu
authors.forename: David
authors.initials: D
authors.lastname: Monfort
authors.forename: German
authors.initials: G
authors.lastname: Soriano
authors.forename: Carmen
authors.initials: C
authors.lastname: Vila
authors.forename: Alberto
authors.initials: A
authors.lastname: Pardo
authors.forename: Enrique
authors.initials: E
authors.lastname: Quintero
authors.forename: Victor
authors.initials: V
authors.lastname: Vargas
authors.forename: Jose
authors.initials: J
authors.lastname: Such
authors.forename: Pere
authors.initials: P
authors.lastname: Ginès
authors.forename: Vicente
authors.initials: V
authors.lastname: Arroyo
mesh_terms: D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D004311:Double-Blind Method; D005260:Female; D006530:Hepatorenal Syndrome / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009643:Norfloxacin / Q000627:therapeutic use*; D010538:Peritonitis / Q000209:etiology / Q000382:microbiology / Q000503:physiopathology / Q000517:prevention & control*; D012307:Risk Factors; D016019:Survival Analysis
chemical_list: D000890:Anti-Infective Agents; D009643:Norfloxacin