Comparison of the effects of albumin and crystalloid on mortality among patients with septic shock: systematic review with meta-analysis and trial sequential analysis

ABSTRACT BACKGROUND: This study aimed to compare the effects on mortality of albumin and crystalloid, used for fluid resuscitation among adult patients with septic shock, through conducting a meta-analysis and trial sequential analysis (TSA). DESIGN AND SETTING: Meta-analysis and TSA conducted at Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai, China. METHODS: Data were collected from several major databases including MEDLINE, EMBASE, Clinical Trials.gov and Cochrane Central Register of Controlled Trials. Studies that compared the effects of albumin therapy versus crystalloid therapy on mortality among adult septic shock patients were eligible for inclusion in the analyses. The study name, year of publication, country of the trial, albumin concentration, type of crystalloid and all reported mortalities at different follow-up endpoints were extracted. RESULTS: Compared with crystalloid, albumin did not decrease all-cause mortality at the final follow-up. However, in TSA, the required information size was not achieved in all groups, which means that the effect size was not definitive and further RCTs are needed to confirm or deny these findings CONCLUSIONS: Compared with crystalloid solutions, albumin was unable to decrease all-cause mortality. However, TSA indicated that these results could be false-negative. Additional randomized controlled trials are needed to clarify this discrepancy.

摘要
研究背景：本研究旨在通过荟萃分析（meta-analysis）与试验序贯分析（trial sequential analysis, TSA），比较白蛋白与晶体液用于感染性休克成年患者液体复苏时对死亡率的影响。
研究设计与实施地点：本研究的荟萃分析与试验序贯分析在中国上海交通大学附属第六人民医院完成。
研究方法：研究数据从MEDLINE、EMBASE、ClinicalTrials.gov及Cochrane对照试验中心注册库等多个主流数据库中检索获取。纳入本研究分析的研究需满足：对比成人感染性休克患者接受白蛋白治疗与晶体液治疗对死亡率的影响。提取内容包括研究名称、发表年份、试验所属国家、白蛋白浓度、晶体液类型，以及不同随访终点下报告的所有死亡率数据。
研究结果：与晶体液相比，白蛋白未降低最终随访节点的全因死亡率。但在试验序贯分析中，所有亚组均未达到所需的信息量，提示当前效应量尚未明确，需开展进一步的随机对照试验（Randomized Controlled Trial, RCT）以验证或推翻上述研究结果。
研究结论：与晶体液相比，白蛋白未能降低成人感染性休克患者的全因死亡率。但试验序贯分析提示，本研究结果可能存在假阴性。需开展更多随机对照试验以阐明这一差异。