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Research Article| Volume 57, ISSUE 4, P759-765, October 2012

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Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study

  • Author Footnotes
    † These authors contributed equally to this work.
    Mónica Guevara
    Footnotes
    † These authors contributed equally to this work.
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain

    Instituto Reina Sofía de Investigación Nefrológica (IRSIN), Spain
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  • Author Footnotes
    † These authors contributed equally to this work.
    Carlos Terra
    Footnotes
    † These authors contributed equally to this work.
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain

    Instituto Reina Sofía de Investigación Nefrológica (IRSIN), Spain
    Search for articles by this author
  • André Nazar
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain

    Instituto Reina Sofía de Investigación Nefrológica (IRSIN), Spain
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  • Elsa Solà
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain

    Instituto Reina Sofía de Investigación Nefrológica (IRSIN), Spain
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  • Javier Fernández
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
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  • Marco Pavesi
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    Search for articles by this author
  • Vicente Arroyo
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    Search for articles by this author
  • Pere Ginès
    Correspondence
    Corresponding author. Address: Liver Unit, Hospital Clínic Villarroel 170, 08036 Barcelona, Spain.
    Affiliations
    Liver Unit, Hospital Clínic, University of Barcelona, Barcelona, Catalunya, Spain

    Institut d’Investigacions Biomèdiques August-Pi-Sunyer (IDIBAPS), Spain

    Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain

    Instituto Reina Sofía de Investigación Nefrológica (IRSIN), Spain
    Search for articles by this author
  • Author Footnotes
    † These authors contributed equally to this work.

      Background & Aims

      Treatment with albumin in patients with cirrhosis and spontaneous bacterial peritonitis (SBP) prevents renal failure and improves survival. Whether albumin has similar beneficial effects in patients with infections other than SBP is unknown.

      Methods

      One hundred and ten patients with cirrhosis hospitalized for infections other than SBP were randomly assigned to receive antibiotics plus albumin (1.5 g/kg bw at diagnosis and 1 g/kg bw at day 3) (albumin group; n = 56) or antibiotics alone (control group; n = 54). The primary end point was survival at 3 months. Secondary end points were effects on renal and circulatory function.

      Results

      The renal function, as evaluated by differences in changes in serum creatinine and estimated glomerular filtration rate between the two groups, improved in patients treated with albumin. The circulatory function improved significantly in patients treated with albumin, but not in those from the control group. There was a trend for a lower frequency of type 1 hepatorenal syndrome in the albumin group compared to the control group (1 vs. 4 patients, respectively; p = n.s.). Probability of survival at 3 months was not significantly different among the two groups. However, when adjusted for factors with independent prognostic value, treatment with albumin was an independent predictive factor of survival.

      Conclusions

      As compared with standard antibiotic therapy alone, treatment with albumin together with antibiotics has beneficial effects on the renal and circulatory function and shows a potential survival benefit. Further studies with large sample sizes should be performed to confirm these findings.

      Abbreviations:

      SBP (spontaneous bacterial peritonitis), PMN (polymorphonuclear), HIV (human immunodeficiency virus), HRS (hepatorenal syndrome), eGFR (estimated glomerular filtration rate), BUN (blood urea nitrogen)

      Keywords

      Linked Article

      • Effect of albumin on survival in septic cirrhotic patients other than spontaneous bacterial peritonitis. The question remains open
        Journal of HepatologyVol. 58Issue 3
        • Preview
          We read the manuscript by Guevara et al. with interest [1]. The authors evaluated the effect of albumin administration on the 3-month survival in cirrhotic patients hospitalized for infections other than spontaneous bacterial peritonitis (SBP). After randomization, 54 and 56 patients received respectively antibiotics alone, and both antibiotics plus intravenous albumin (1.5 g/kg the first day and 1 g/kg at day 3). The authors concluded that albumin administration with antibiotics showed a potential survival benefit in per-protocol analysis as compared with the control group, and that such a beneficial effect was probably due to the improvement in effective arterial blood volume reflected by the improvement in renal function.
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      • Reply to: “Effect of albumin on survival in septic cirrhotic patients other than spontaneous bacterial peritonitis. The question remains open”
        Journal of HepatologyVol. 58Issue 3
        • Preview
          We would like to thank Dr. Thevenot et al. for their interest in our study on the effect of albumin administration in patients with cirrhosis and infections other than spontaneous bacterial peritonitis [1]. Our answers to their comments are as follows: (1) the statistical difference between the per-protocol analysis and intention-to-treat analysis is minimal, as indicated by their corresponding hazard ratios (0.29 and 0.35, respectively) and p values (0.042 and 0.06), despite the fact that the latter falls outside the level of significance.
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      References

        • Fernández J.
        • Navasa M.
        • Gómez J.
        • Colmenero J.
        • Vila J.
        • Arroyo V.
        • et al.
        Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis.
        Hepatology. 2002; 35: 140-148
        • Wong F.
        • Bernardi M.
        • Balk R.
        • Christman B.
        • Moreau R.
        • Garcia G.
        • et al.
        International Ascites Club. Sepsis in cirrhosis: report on the 7th meeting of the International Ascites Club.
        Gut. 2005; 54: 718-725
        • Tandon P.
        • Garcia-Tsao G.
        Bacterial infections, sepsis, and multiorgan failure in cirrhosis.
        Semin Liver Dis. 2008; 28: 26-42
        • Arvaniti V.
        • D’Amico G.
        • Fede G.
        • Manousou P.
        • Tsochatzis E.
        • Pleguezuelo M.
        • et al.
        Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis.
        Gastroenterology. 2010; 139: 1246-1256
        • Follo A.
        • Llovet J.M.
        • Navasa M.
        • Planas R.
        • Forns X.
        • Francitorra A.
        • et al.
        Renal impairment after spontaneous bacterial peritonitis in cirrhosis: incidence, clinical course, predictive factors and prognosis.
        Hepatology. 1994; 20: 1495-1501
        • Navasa M.
        • Follo A.
        • Filella X.
        • Jiménez W.
        • Francitorra A.
        • Planas R.
        • et al.
        Tumor necrosis factor and interleukin-6 in spontaneous bacterial peritonitis in cirrhosis: relationship with the development of renal impairment and mortality.
        Hepatology. 1998; 27: 1227-1232
        • Gustot T.
        • Durand F.
        • Lebrec D.
        • Vincent J.L.
        • Moreau R.
        Severe sepsis in cirrhosis.
        Hepatology. 2009; 50: 2022-2033
        • Runyon B.A.
        Albumin infusion for spontaneous bacterial peritonitis.
        Lancet. 1999; 354: 1838-1839
        • Angeli P.
        • Guarda S.
        • Fasolato S.
        • Miola E.
        • Craighero R.
        • Piccolo F.
        • et al.
        Switch therapy with ciprofloxacin vs. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis: similar efficacy at lower cost.
        Aliment Pharmacol Ther. 2006; 23: 75-84
        • Tandon P.
        • Garcia-Tsao G.
        Renal dysfunction is the most important independent predictor of mortality in cirrhotic patients with spontaneous bacterial peritonitis.
        Clin Gastroenterol Hepatol. 2011; 9: 260-265
        • Fasolato S.
        • Angeli P.
        • Dallagnese L.
        • Maresio G.
        • Zola E.
        • Mazza E.
        • et al.
        Renal failure and bacterial infections in patients with cirrhosis: epidemiology and clinical features.
        Hepatology. 2007; 45: 223-229
        • Terra C.
        • Guevara M.
        • Torre A.
        • Gilabert R.
        • Fernández J.
        • Martín-Llahí M.
        • et al.
        Renal failure in patients with cirrhosis and sepsis unrelated to spontaneous bacterial peritonitis: value of MELD score.
        Gastroenterology. 2005; 129: 1944-1953
        • Pereira G.
        • Fagundes C.
        • Guevara M.
        • Solà E.
        • Rodríguez E.
        • Fernández J.
        • et al.
        Renal failure and hyponatremia in patients with cirrhosis and skin and soft tissue infection. A retrospective study.
        J Hepatol. 2012; 56: 1040-1046
        • Ruiz-del-Arbol L.
        • Urman J.
        • Fernández J.
        • González M.
        • Navasa M.
        • Monescillo A.
        • et al.
        Systemic, renal, and hepatic hemodynamic derangement in cirrhotic patients with spontaneous bacterial peritonitis.
        Hepatology. 2003; 38: 1210-1218
        • Fernández J.
        • Monteagudo J.
        • Bargallo X.
        • Jiménez W.
        • Bosch J.
        • Arroyo V.
        • et al.
        A randomized unblinded pilot study comparing albumin versus hydroxyethyl starch in spontaneous bacterial peritonitis.
        Hepatology. 2005; 42: 627-634
        • Such J.
        • Hillebrand D.J.
        • Guarner C.
        • Berk L.
        • Zapater P.
        • Westengard J.
        • et al.
        Nitric oxide in ascitic fluid is an independent predictor of the development of renal impairment in patients with cirrhosis and spontaneous bacterial peritonitis.
        Eur J Gastroenterol Hepatol. 2004; 16: 571-577
        • Propst T.
        • Propst A.
        • Herold M.
        • Judmaier G.
        • Braunsteiner H.
        • Vogel W.
        High levels of interleukin-6 and its secondary mediators in spontaneous bacterial peritonitis.
        Gastroenterology. 1993; 105: 310-311
        • Fernández J.
        • Navasa M.
        • Garcia-Pagan J.C.
        • G-Abraldes J.
        • Jiménez W.
        • et al.
        Effect of intravenous albumin on systemic and hepatic hemodynamics and vasoactive neurohormonal systems in patients with cirrhosis and spontaneous bacterialperitonitis.
        J Hepatol. 2004; 41: 384-390
        • Sort P.
        • Navasa M.
        • Arroyo V.
        • Aldeguer X.
        • Planas R.
        • Ruiz-del-Arbol L.
        • et al.
        Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis.
        New Engl J Med. 1999; 341: 403-409
        • Arroyo V.
        Human serum albumin: not just a plasma volume expander.
        Hepatology. 2009; 50: 355-357
        • Quinlan G.J.
        • Martin G.S.
        • Evans T.W.
        Albumin: biochemical properties and therapeutic potencial.
        Hepatology. 2005; 41: 1211-1219
        • Arroyo V.
        Review article: albumin in the treatment of liver diseases––new features of a classical treatment.
        Aliment Pharmacol Ther. 2002; 16 (Suppl. 5): 1-5
        • Moore K.P.
        • Aithal G.P.
        Guidelines on the management of ascites in cirrhosis.
        Gut. 2006; 55 (Suppl. 6): 1-12
        • Garcia-Tsao G.
        Members of Veterans Affairs Hepatitis C Resource Center Program. Management and treatment of patients with cirrhosis and portal hypertension: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program.
        Am J Gastroenterol. 2009; 104: 1802-1829
        • Runyon B.A.
        • AASLD Practice Guidelines Committee
        Management of adult patients with ascites due to cirrhosis: an update.
        Hepatology. 2009; 49: 2087-2107
        • Ginès P.
        • Angeli P.
        • Lenz K.
        • Moller S.
        • Moore K.
        • Moreu R.
        • et al.
        European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis.
        J Hepatol. 2010; 53: 397-417
        • Uriz J.
        • Ginès P.
        • Cárdenas A.
        • Sort P.
        • Jiménez W.
        • Salmerón J.M.
        • et al.
        Terlipressin plus albumin infusion: an effective and safe therapy of hepatorenal syndrome.
        J Hepatol. 2000; 33: 43-48
        • Guevara M.
        • Ginès P.
        • Fernandez-Esparrach G.
        • Sort P.
        • Salmeron J.M.
        • Jimenez W.
        • et al.
        Reversibility of hepatorenal syndrome by prolonged administration of ornipressin and plasma volume expansion.
        Hepatology. 1998; 1: 35-41
        • Fernández J.
        • Gustot T.
        Management of bacterial infections in cirrhosis.
        J Hepatol. 2012; 56: S1-S12
        • Cardenas A.
        • Ginès P.
        Management of patients with cirrhosis awaiting liver transplantation.
        J Hepatol. 2005; 42: S124-S133
        • Levey A.S.
        • Greene T.
        • Kusek J.W.
        • Beck G.L.
        MDRD Study Group. A simplified equation to predict glomerular filtration rate from serum creatinine.
        J Am Soc Nephrol. 2000; 11: 155A
        • Levy M.M.
        • Fink M.P.
        • Marshall J.C.
        • Abraham E.
        • Angus D.
        • Cook D.
        • International Sepsis Definitions Conference
        • et al.
        2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference.
        Int Care Med. 2003; 29: 530-538
        • Martín-Llahí M.
        • Guevara M.
        • Torre A.
        • Fagundes C.
        • Restuccia T.
        • Gilabert R.
        • et al.
        Prognostic importance of the cause of renal failure in patients with cirrhosis.
        Gastroenterology. 2011; 140: 488-496
        • Thabut D.
        • Massard J.
        • Gangloff A.
        • Carbonell N.
        • Francoz C.
        • Nguyen-Khac E.
        • et al.
        Model for end-stage liver disease score and systemic inflammatory response are major prognostic factors in patients with cirrhosis and acute functional renal failure.
        Hepatology. 2007; 46: 1872-1882
        • Terg R.
        • Gadano A.
        • Cartier M.
        • Casciato P.
        • Lucero R.
        • Muñoz A.
        • et al.
        Serum creatinine and bilirubin predict renal failure and mortality in patients with spontaneous bacterial peritonitis: a retrospective study.
        Liver Int. 2009; 29: 415-419
        • Sigal S.H.
        • Stanca C.M.
        • Fernandez J.
        • Arroyo V.
        • Navasa M.
        Restricted use of albumin for spontaneous bacterial peritonitis.
        Gut. 2007; 56: 597-599