NEJM：白蛋白替代晶体治疗脓毒症并无优势

南粤麻医

http://www.nejm.org/doi/full/10.1056/NEJMoa1305727

今日出版的NEJM杂志发表重磅级研究，该多中心研究观察使用白蛋白代替晶体液治疗（白蛋白+晶体液）较仅使用晶体液治疗脓毒症患者的情况，结果发现两组间在28天及90天死亡率之间并无显著差异。

ORIGINAL ARTICLE

Albumin Replacement in Patients with Severe Sepsis or Septic Shock

Pietro Caironi, M.D., Gianni Tognoni, M.D., Serge Masson, Ph.D., Roberto Fumagalli, M.D., Antonio Pesenti, M.D., Marilena Romero, Ph.D., Caterina Fanizza, M.Stat., Luisa Caspani, M.D., Stefano Faenza, M.D., Giacomo Grasselli, M.D., Gaetano Iapichino, M.D., Massimo Antonelli, M.D., Vieri Parrini, M.D., Gilberto Fiore, M.D., Roberto Latini, M.D., and Luciano Gattinoni, M.D. for the ALBIOS Study Investigators

N Engl J Med 2014; 370:1412-1421April 10, 2014DOI: 10.1056/NEJMoa1305727

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.)