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N Engl J Med. 2014 Apr 10;370(15):1412-21. doi: 10.1056/NEJMoa1305727. Epub 2014 Mar 18.

Albumin replacement in patients with severe sepsis or septic shock.

Collaborators (209)

Gattinoni L, Caironi P, Pesenti A, Fumagalli R, Tognoni G, Romero M, Latini R, Masson S, Vincent JL, Suter PM, Valsecchi MG, Santosuosso A, Cavana M, Ortu A, Gabini R, Perno S, Anelli A, Amoruso R, Ferraris S, Borelli M, Massei R, Riva I, Poli G, Papagni G, Bortone F, Mamprin F, Keim R, Brivio M, Colageo U, Mimii EP, Sangiorgi G, Siniscalchi A, Pierucci E, Giovannitti A, Gentile C, Pascucci F, Antonini B, Zummo U, Valsecchi R, Cerisara M, Trezzi T, Dossena A, Ribola A, Tamayo L, Zoppellari R, Volta CA, Mangani V, Fanfani E, Chelazzi C, Bartoli T, Parrini V, Oggioni R, Fedele A, Molin A, Berri C, Guarino A, Isetta M, Bonfiglio M, Tissino F, Silvestri L, Milanesi M, Sbrana G, Motta E, Iannaco I, Casadio MC, Pasetti GS, Palandini A, Cascione C, Puscio D, Cellai F, Boccalatte D, Silvestri S, Fausto CI, Lupo V, Zompanti V, Iacobone E, Gattari D, Ronzoni G, Beck E, Francesconi S, Colombo R, Raimondi F, Castelli A, De Gasperi A, Radrizzani D, Ferla LE, Giudici R, Bellato V, Bordone G, Gavazzeni V, Lesmo A, Ripamonti D, Vesconi S, Papoff A, Rossi A, Noto A, Pezzi A, Zanforlin G, Kandil H, Ballotta A, Bettini F, Vaghi GM, Rossi S, Pessina C, Casagrande D, Trivellato A, Costagli V, Moise G, Furla M, Marelli S, Caspani L, Panigada M, Bruzzone P, Isgrò S, Abbruzzese C, Tagliabue P, Solca M, Bonazzi M, Cattaneo A, Rossi N, Andreoni P, Pasetto A, Girardis M, Barbieri E, Piazza O, Giarratano A, Raineri SM, Cortegiani A, Zagara G, Bono M, Galzerano A, Garzilli T, Dentini N, Bindi M, Biancofiore G, Mercante WP, Disconzi MM, Todesco N, Lunardi S, Sani E, Carli M, Bracciotti G, Gori V, Braccini P, Maggio G, Braschi A, Bottazzi A, Iotti G, Nicora B, Salati G, Salsi P, Antonelli M, Pennisi MA, Bello G, Caccese R, D'Ambrosio M, Rocco M, Sanseverino M, Gatta A, Nastasi M, Corsi A, Facondini F, Franchi F, Mongelli P, Ferrario M, Carulli F, Del Curto S, Schiappacasse G, Dalpiaz C, Armani S, Verderosa I, Marzullo A, Tonetti F, De Piero ME, Livigni S, Fiore G, Cerutti A, Erbetta S, Napolitano R, Pastorelli M, Bona F, Debernardi F, Gallo M, Segala V, Parigi L, Perzolla D, Marson F, Chiarandini P, Cammarano C, Sermann G, De Lucia S, Frigerio A, Distaso F, Franco R, Bossi E, Laudi C, De Nardin M, Violo T, Lazzari F, Vestali A, Della Mora E, Polati E, Martini A, Cristallini S, Totaro C, Milan B, Dan M, Ruberti S, Danzi V.

Author information

1
From Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca' Granda-Ospedale Maggiore Policlinico, Università degli Studi di Milano (P.C., G.I., L.G.), Dipartimento di Anestesia, Rianimazione e Terapia del Dolore, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico (P.C., L.C., L.G.), IRCCS-Istituto di Ricerche Farmacologiche Mario Negri (S.M., R.L.), Dipartimento di Scienze della Salute, Università degli Studi di Milano Bicocca (R.F., A.P.), and Dipartimento di Emergenza-Urgenza, Azienda Ospedaliera S. Paolo-Polo Universitario (G.I.), Milan, Consorzio Mario Negri Sud, Santa Maria Imbaro (G.T., M.R., C.F.), Anestesiologia e Rianimazione, Dipartimento Emergenza-Urgenza, Chirurgia Generale e dei Trapianti, Policlinico Universitario S. Orsola Malpighi, Bologna (S.F.), Dipartimento di Emergenza-Urgenza, Azienda Ospedaliera S. Gerardo, Monza (G.G.), Policlinico Universitario A. Gemelli, Università Cattolica, Rome (M.A.), Ospedale del Mugello-Azienda Sanitaria di Firenze, Florence (V.P.), and Ospedale S. Croce, Moncalieri (G.F.) - all in Italy.

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.).

PMID:
24635772
DOI:
10.1056/NEJMoa1305727
[Indexed for MEDLINE]
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