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首页> 外文期刊>The New England journal of medicine >Albumin replacement in patients with severe sepsis or septic shock
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Albumin replacement in patients with severe sepsis or septic shock

机译：患有严重脓毒症或脓肠梗休克患者的白蛋白替代品

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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.)
机译：背景：尽管以前的研究表明，患有严重败血症患者的白蛋白给药潜在优势，但其功效尚未完全建立。方法：在该多中心，开放标签试验中，我们随机分配了1818名患有的严重脓毒症患者，100个重症监护单位（ICU），仅接收20％白蛋白和晶体溶液或晶体溶液。在白蛋白组中，靶血清白蛋白浓度为每升30克或更高直至随机化后从ICU或28天排出。主要结果在28天的任何原因中都是死亡。二次结果是从90天发生的任何原因死亡，器官功能障碍患者的数量和ICU和医院的功能障碍程度和逗留时间。结果：在前7天内，与晶体基团中的患者相比，白蛋白组的患者具有更高的平均动脉压（P = 0.03）和较低的净液平衡（P <0.001）。在两组之间的施用流体的总量没有显着差异（P = 0.10）。在28天，白蛋白组中895名患者（31.8％），并在晶体组900 288（32.0％）285已经死亡白蛋白组中（相对风险，1.00; 95％置信区间[CI]，0.87〜 1.14; p = 0.94）。在90天，在白蛋白组中的888名患者（41.1％）的365名中，晶体基团中的389名（43.6％）死亡（相对风险，0.94; 95％CI，0.85至1.05; p = 0.29）。两组之间没有观察到其他二次结果的显着差异。结论：在患有严重脓毒症的患者中，除了单独的晶体外除了晶体外，白蛋白除了晶体外，还没有提高28和90天的存活率。 （由意大利药物局资助; Albios Clinicaltrials.gov号码，NCT00707122。）

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  • 来源
    《The New England journal of medicine》 |2014年第15期|共10页
  • 作者

    CaironiP.; TognoniG.; MassonS.; FumagalliR.; PesentiA.; RomeroM.; FanizzaC.; CaspaniL.; FaenzaS.; GrasselliG.; IapichinoG.; AntonelliM.; ParriniV.; FioreG.; LatiniR.; GattinoniL.;

  • 作者单位

    Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti Fondazione (IRCCS) Ca' Granda;

    Consorzio Mario Negri Sud Santa Maria Imbaro Italy;

    IRCCS-Istituto di Ricerche Farmacologiche Mario Negri Italy;

    Dipartimento di Scienze Della Salute Università degli Studi di Milano Bicocca Italy;

    Dipartimento di Scienze Della Salute Università degli Studi di Milano Bicocca Italy;

    Consorzio Mario Negri Sud Santa Maria Imbaro Italy;

    Consorzio Mario Negri Sud Santa Maria Imbaro Italy;

    Dipartimento di Anestesia Rianimazione e Terapia del Dolore Fondazione IRCCS Ca' Granda-Ospedale;

    Anestesiologia e Rianimazione Dipartimento Emergenza-Urgenza Policlinico Universitario S. Orsola;

    Dipartimento di Emergenza-Urgenza Azienda Ospedaliera S. Gerardo Monza Italy;

    Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti Fondazione (IRCCS) Ca' Granda;

    Policlinico Universitario A. Gemelli Università Cattolica Rome Italy;

    Ospedale del Mugello-Azienda Sanitaria di Firenze Florence Italy;

    Ospedale S. Croce Moncalieri Italy;

    IRCCS-Istituto di Ricerche Farmacologiche Mario Negri Italy;

    Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti Fondazione (IRCCS) Ca' Granda;

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