Albumin replacement in patients with severe sepsis or septic shock
Pietro Caironi, Gianni Tognoni, Serge Masson, Roberto Fumagalli, Antonio Pesenti, Marilena Romero, Caterina Fanizza, Luisa Caspani, Stefano Faenza, Giacomo Grasselli, Gaetano Iapichino, Massimo Antonelli, Vieri Parrini, Gilberto Fiore, Roberto Latini, Luciano Gattinoni, ALBIOS Study Investigators, Luciano Gattinoni, Pietro Caironi, Antonio Pesenti, Roberto Fumagalli, Gianni Tognoni, Marilena Romero, Roberto Latini, Serge Masson, Jean Louis Vincent, Peter M Suter, Maria Grazia Valsecchi, Amedeo Santosuosso, Marco Cavana, Andrea Ortu, Rita Gabini, Silvia Perno, Antonio Anelli, Rosa Amoruso, Sandra Ferraris, Massimo Borelli, Riccardo Massei, Ivano Riva, Giancarla Poli, Gabriele Papagni, Franco Bortone, Filippo Mamprin, Roberto Keim, Matteo Brivio, Umberto Colageo, Emanuela Pascu Mimii, Gabriela Sangiorgi, Antonio Siniscalchi, Elisabetta Pierucci, Alfonso Giovannitti, Carlo Gentile, Federico Pascucci, Benvenuto Antonini, Ugo Zummo, Roberto Valsecchi, Marco Cerisara, Tommaso Trezzi, Agostino Dossena, Angela Ribola, Leonor Tamayo, Roberto Zoppellari, Carlo Alberto Volta, Valerio Mangani, Elena Fanfani, Cosimo Chelazzi, Teresa Bartoli, Vieri Parrini, Roberto Oggioni, Andrea Fedele, Alexandra Molin, Chiara Berri, Arturo Guarino, Michele Isetta, Monica Bonfiglio, Francesca Tissino, Luciano Silvestri, Marco Milanesi, Giovanni Sbrana, Elisa Motta, Irene Iannaco, Maria Cinza Casadio, Giovanni Stefano Pasetti, Alessandra Palandini, Cristian Cascione, Daniela Puscio, Ferdinando Cellai, Daniela Boccalatte, Simone Silvestri, Carlo Iacopo Fausto, Valeria Lupo, Valeria Zompanti, Emanuele Iacobone, Diego Gattari, Giulio Ronzoni, Eduardo Beck, Silvia Francesconi, Riccardo Colombo, Ferdinando Raimondi, Antonio Castelli, Andrea De Gasperi, Danilo Radrizzani, Luca Emilio Mario Ferla, Riccardo Giudici, Valentina Bellato, Giovanni Bordone, Vittorio Gavazzeni, Andrea Lesmo, Donata Ripamonti, Sergio Vesconi, Alessandra Papoff, Anna Rossi, Andrea Noto, Angelo Pezzi, Giancarlo Zanforlin, Hassan Kandil, Andrea Ballotta, Fabrizio Bettini, Giuseppe Massimo Vaghi, Simona Rossi, Carla Pessina, Davide Casagrande, Adino Trivellato, Valerio Costagli, Gabriella Moise, Mirella Furla, Silvia Marelli, Luisa Caspani, Mauro Panigada, Paola Bruzzone, Stefano Isgrò, Chiara Abbruzzese, Paola Tagliabue, Maurizio Solca, Maurizio Bonazzi, Ambrogina Cattaneo, Nicola Rossi, Patrizia Andreoni, Alberto Pasetto, Massimo Girardis, Elisa Barbieri, Ornella Piazza, Antonino Giarratano, Santi Maurizio Raineri, Andrea Cortegiani, Giovanni Zagara, Monia Bono, Antonio Galzerano, Tiziana Garzilli, Nadia Dentini, Maria Bindi, Gianni Biancofiore, Willy Pierre Mercante, Mara Maria Disconzi, Nadia Todesco, Stefano Lunardi, Emanuele Sani, Manuela Carli, Giovanna Bracciotti, Valentina Gori, Paola Braccini, Giuseppe Maggio, Antonio Braschi, Andrea Bottazzi, Giorgio Iotti, Bruno Nicora, Giovanni Salati, Pierpaolo Salsi, Massimo Antonelli, Mariano Alberto Pennisi, Giuseppe Bello, Roberta Caccese, Mario D'Ambrosio, Monica Rocco, Manlio Sanseverino, Alessandro Gatta, Mauro Nastasi, Amedeo Corsi, Francesca Facondini, Federico Franchi, Pierpaolo Mongelli, Matteo Ferrario, Francesco Carulli, Simone Del Curto, Giuseppe Schiappacasse, Chiara Dalpiaz, Stefania Armani, Ivo Verderosa, Antonella Marzullo, Federica Tonetti, Maria Elena De Piero, Sergio Livigni, Gilberto Fiore, Alessandro Cerutti, Simona Erbetta, Rita Napolitano, Mauro Pastorelli, Francesco Bona, Felicino Debernardi, Mauro Gallo, Vincenzo Segala, Luigi Parigi, Davide Perzolla, Franco Marson, Paolo Chiarandini, Cinzia Cammarano, Giovanni Sermann, Samuele De Lucia, Alice Frigerio, Francesco Distaso, Roberto Franco, Emanuele Bossi, Claudio Laudi, Marco De Nardin, Terenzio Violo, Francesco Lazzari, Agostino Vestali, Ernesto Della Mora, Enrico Polati, Alvise Martini, Stefano Cristallini, Cosimo Totaro, Beatrice Milan, Maurizio Dan, Serena Ruberti, Vinicio Danzi, Pietro Caironi, Gianni Tognoni, Serge Masson, Roberto Fumagalli, Antonio Pesenti, Marilena Romero, Caterina Fanizza, Luisa Caspani, Stefano Faenza, Giacomo Grasselli, Gaetano Iapichino, Massimo Antonelli, Vieri Parrini, Gilberto Fiore, Roberto Latini, Luciano Gattinoni, ALBIOS Study Investigators, Luciano Gattinoni, Pietro Caironi, Antonio Pesenti, Roberto Fumagalli, Gianni Tognoni, Marilena Romero, Roberto Latini, Serge Masson, Jean Louis Vincent, Peter M Suter, Maria Grazia Valsecchi, Amedeo Santosuosso, Marco Cavana, Andrea Ortu, Rita Gabini, Silvia Perno, Antonio Anelli, Rosa Amoruso, Sandra Ferraris, Massimo Borelli, Riccardo Massei, Ivano Riva, Giancarla Poli, Gabriele Papagni, Franco Bortone, Filippo Mamprin, Roberto Keim, Matteo Brivio, Umberto Colageo, Emanuela Pascu Mimii, Gabriela Sangiorgi, Antonio Siniscalchi, Elisabetta Pierucci, Alfonso Giovannitti, Carlo Gentile, Federico Pascucci, Benvenuto Antonini, Ugo Zummo, Roberto Valsecchi, Marco Cerisara, Tommaso Trezzi, Agostino Dossena, Angela Ribola, Leonor Tamayo, Roberto Zoppellari, Carlo Alberto Volta, Valerio Mangani, Elena Fanfani, Cosimo Chelazzi, Teresa Bartoli, Vieri Parrini, Roberto Oggioni, Andrea Fedele, Alexandra Molin, Chiara Berri, Arturo Guarino, Michele Isetta, Monica Bonfiglio, Francesca Tissino, Luciano Silvestri, Marco Milanesi, Giovanni Sbrana, Elisa Motta, Irene Iannaco, Maria Cinza Casadio, Giovanni Stefano Pasetti, Alessandra Palandini, Cristian Cascione, Daniela Puscio, Ferdinando Cellai, Daniela Boccalatte, Simone Silvestri, Carlo Iacopo Fausto, Valeria Lupo, Valeria Zompanti, Emanuele Iacobone, Diego Gattari, Giulio Ronzoni, Eduardo Beck, Silvia Francesconi, Riccardo Colombo, Ferdinando Raimondi, Antonio Castelli, Andrea De Gasperi, Danilo Radrizzani, Luca Emilio Mario Ferla, Riccardo Giudici, Valentina Bellato, Giovanni Bordone, Vittorio Gavazzeni, Andrea Lesmo, Donata Ripamonti, Sergio Vesconi, Alessandra Papoff, Anna Rossi, Andrea Noto, Angelo Pezzi, Giancarlo Zanforlin, Hassan Kandil, Andrea Ballotta, Fabrizio Bettini, Giuseppe Massimo Vaghi, Simona Rossi, Carla Pessina, Davide Casagrande, Adino Trivellato, Valerio Costagli, Gabriella Moise, Mirella Furla, Silvia Marelli, Luisa Caspani, Mauro Panigada, Paola Bruzzone, Stefano Isgrò, Chiara Abbruzzese, Paola Tagliabue, Maurizio Solca, Maurizio Bonazzi, Ambrogina Cattaneo, Nicola Rossi, Patrizia Andreoni, Alberto Pasetto, Massimo Girardis, Elisa Barbieri, Ornella Piazza, Antonino Giarratano, Santi Maurizio Raineri, Andrea Cortegiani, Giovanni Zagara, Monia Bono, Antonio Galzerano, Tiziana Garzilli, Nadia Dentini, Maria Bindi, Gianni Biancofiore, Willy Pierre Mercante, Mara Maria Disconzi, Nadia Todesco, Stefano Lunardi, Emanuele Sani, Manuela Carli, Giovanna Bracciotti, Valentina Gori, Paola Braccini, Giuseppe Maggio, Antonio Braschi, Andrea Bottazzi, Giorgio Iotti, Bruno Nicora, Giovanni Salati, Pierpaolo Salsi, Massimo Antonelli, Mariano Alberto Pennisi, Giuseppe Bello, Roberta Caccese, Mario D'Ambrosio, Monica Rocco, Manlio Sanseverino, Alessandro Gatta, Mauro Nastasi, Amedeo Corsi, Francesca Facondini, Federico Franchi, Pierpaolo Mongelli, Matteo Ferrario, Francesco Carulli, Simone Del Curto, Giuseppe Schiappacasse, Chiara Dalpiaz, Stefania Armani, Ivo Verderosa, Antonella Marzullo, Federica Tonetti, Maria Elena De Piero, Sergio Livigni, Gilberto Fiore, Alessandro Cerutti, Simona Erbetta, Rita Napolitano, Mauro Pastorelli, Francesco Bona, Felicino Debernardi, Mauro Gallo, Vincenzo Segala, Luigi Parigi, Davide Perzolla, Franco Marson, Paolo Chiarandini, Cinzia Cammarano, Giovanni Sermann, Samuele De Lucia, Alice Frigerio, Francesco Distaso, Roberto Franco, Emanuele Bossi, Claudio Laudi, Marco De Nardin, Terenzio Violo, Francesco Lazzari, Agostino Vestali, Ernesto Della Mora, Enrico Polati, Alvise Martini, Stefano Cristallini, Cosimo Totaro, Beatrice Milan, Maurizio Dan, Serena Ruberti, Vinicio Danzi
Abstract
Background: Although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis, its efficacy has not been fully established.
Methods: In this multicenter, open-label trial, we randomly assigned 1818 patients with severe sepsis, in 100 intensive care units (ICUs), to receive either 20% albumin and crystalloid solution or crystalloid solution alone. In the albumin group, the target serum albumin concentration was 30 g per liter or more until discharge from the ICU or 28 days after randomization. The primary outcome was death from any cause at 28 days. Secondary outcomes were death from any cause at 90 days, the number of patients with organ dysfunction and the degree of dysfunction, and length of stay in the ICU and the hospital.
Results: During the first 7 days, patients in the albumin group, as compared with those in the crystalloid group, had a higher mean arterial pressure (P=0.03) and lower net fluid balance (P<0.001). The total daily amount of administered fluid did not differ significantly between the two groups (P=0.10). At 28 days, 285 of 895 patients (31.8%) in the albumin group and 288 of 900 (32.0%) in the crystalloid group had died (relative risk in the albumin group, 1.00; 95% confidence interval [CI], 0.87 to 1.14; P=0.94). At 90 days, 365 of 888 patients (41.1%) in the albumin group and 389 of 893 (43.6%) in the crystalloid group had died (relative risk, 0.94; 95% CI, 0.85 to 1.05; P=0.29). No significant differences in other secondary outcomes were observed between the two groups.
Conclusions: In patients with severe sepsis, albumin replacement in addition to crystalloids, as compared with crystalloids alone, did not improve the rate of survival at 28 and 90 days. (Funded by the Italian Medicines Agency; ALBIOS ClinicalTrials.gov number, NCT00707122.).
Source: PubMed