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.
N Engl J Med. 2014 Apr 10;370(15):1412-21. doi: 10.1056/NEJMoa1305727. Epub 2014 Mar 18.
Although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis, its efficacy has not been fully established.
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.
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.
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.).
尽管先前的研究表明在严重脓毒症患者中使用白蛋白可能具有优势，但它的疗效尚未得到充分证实。
在这项多中心、开放标签试验中，我们将 1818 例严重脓毒症患者在 100 个重症监护病房（ICU）中随机分为两组，分别接受白蛋白和晶体溶液或单独晶体溶液治疗。在白蛋白组中，目标血清白蛋白浓度为 30 克/升或更高，直至从 ICU 出院或随机分组后 28 天。主要结局是 28 天内的任何原因死亡。次要结局是 90 天内的任何原因死亡、器官功能障碍的患者数量和功能障碍程度以及 ICU 和医院的住院时间。
在第 7 天内，与晶体组相比，白蛋白组的平均动脉压更高（P=0.03），净液体平衡更低（P<0.001）。两组每日总输液量无显著差异（P=0.10）。28 天时，白蛋白组 895 例患者中有 285 例（31.8%）和晶体组 900 例患者中有 288 例（32.0%）死亡（白蛋白组的相对风险为 1.00；95%置信区间[CI]为 0.87 至 1.14；P=0.94）。90 天时，白蛋白组 888 例患者中有 365 例（41.1%）和晶体组 893 例患者中有 389 例（38.6%）死亡（相对风险，0.94；95%CI，0.85 至 1.05；P=0.29）。两组间其他次要结局无显著差异。
在严重脓毒症患者中，与单独使用晶体溶液相比，在晶体溶液中补充白蛋白并未提高 28 天和 90 天的生存率。（由意大利药品管理局资助；ALBIOS ClinicalTrials.gov 编号：NCT00707122）。
