Gastroenterology
Volume 133, Issue 3 , Pages 818-824, September 2007

Primary Prophylaxis of Spontaneous Bacterial Peritonitis Delays Hepatorenal Syndrome and Improves Survival in Cirrhosis

  • Javier Fernández

      Affiliations

    • Liver Unit, Hospital Clínic Barcelona, Barcelona, Spain
  • ,
  • Miquel Navasa

      Affiliations

    • Liver Unit, Hospital Clínic Barcelona, Barcelona, Spain
    • Corresponding Author InformationAddress requests for reprints to: Miquel Navasa, MD, Liver Unit, Hospital Clínic, Villarroel 170, 08036 Barcelona, Spain. fax: (34) 93-4515522.
  • ,
  • Ramón Planas

      Affiliations

    • Gastroenterology Unit, Hospital Germans Trias i Pujol, Barcelona, Spain
  • ,
  • Silvia Montoliu

      Affiliations

    • Gastroenterology Unit, Hospital Germans Trias i Pujol, Barcelona, Spain
  • ,
  • David Monfort

      Affiliations

    • Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain
  • ,
  • German Soriano

      Affiliations

    • Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain
  • ,
  • Carmen Vila

      Affiliations

    • Gastroenterology Unit, Hospital del Mar, Barcelona, Spain
  • ,
  • Alberto Pardo

      Affiliations

    • Gastroenterology Unit, Hospital Universitario de Canarias, Tenerife, Spain
  • ,
  • Enrique Quintero

      Affiliations

    • Gastroenterology Unit, Hospital Universitario de Canarias, Tenerife, Spain
  • ,
  • Victor Vargas

      Affiliations

    • Gastroenterology Unit, Hospital Vall d’Hebron, Barcelona, Spain
  • ,
  • Jose Such

      Affiliations

    • Gastroenterology Unit, Hospital Universitario, Alicante, Spain
  • ,
  • Pere Ginès

      Affiliations

    • Liver Unit, Hospital Clínic Barcelona, Barcelona, Spain
  • ,
  • Vicente Arroyo

      Affiliations

    • Liver Unit, Hospital Clínic Barcelona, Barcelona, Spain

Received 19 December 2006; accepted 17 May 2007. published online 05 July 2007.

Background & Aims: 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 ≥ 9 points with serum bilirubin level ≥ 3 mg/dL) or impaired renal function (serum creatinine level ≥ 1.2 mg/dL, blood urea nitrogen level ≥ 25 mg/dL, or serum sodium level ≤ 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.

Abbreviations used in this paper: HRS, hepatorenal syndrome, SBP, spontaneous bacterial peritonitis

 

 Supported by grants from the Fondo de Investigación Sanitaria (FIS 00/0921) and the Instituto de Salud Carlos III (BEFI 00/9380 and C03/02).

 ClinicalTrials.gov number: NCT00359853.

PII: S0016-5085(07)01298-X

doi:10.1053/j.gastro.2007.06.065

Refers to article:

  • A Pill a Day Can Improve Survival in Patients With Advanced Cirrhosis

    Bruce A. Runyon
    Gastroenterology September 2007 (Vol. 133, Issue 3, Pages 1029-1031)

Gastroenterology
Volume 133, Issue 3 , Pages 818-824, September 2007