Clinical Efficacy

该子项目的主要目标是检验以下顺序假设： 1）：方案复苏上级常规护理（A组和B组合并的平均死亡率< C组死亡率）。 2）：Rivers方案上级于McKendry-Singer方案（A组的死亡率<A组的死亡率）。 臂B）。 我们提出了一项前瞻性、随机化、三臂平行组试验，旨在研究不同的复苏策略， 早期感染性休克这三种武器是：A。里弗斯协议; B. McKendry-Singer方案;和C.往常 在乎按顺序检验的主要假设是： 住院死亡率高于常规护理（A组和B组与C组），复苏目标是实现正常 ScvO 2（Rivers方案）导致的住院死亡率低于液体复苏和血压控制 单独（McKendry-Singer方案）（A组vs. B组）。将在所有入组受试者中检验这些假设 经过意向性治疗分析。该研究将在分布于19家医院的1950例受试者中入组 在匹兹堡大学的协调下，在美国各地进行。这项研究旨在发现 两种假设的死亡率均为20%。

The primary objectives of this subproject are to test the sequential hypotheses: 1): Protocolized resuscitation is superior to usual care (mean mortality of arms A&B combined < mortality of arm C). 2): The Rivers protocol is superior to the McKendry-Singer protocol (mortality of arm A < mortality of arm B). We propose a prospective, randomized, three-arm parallel-group trial of alternative resuscitation strategies for early septic shock. The three arms are: A. the Rivers protocol; B. the McKendry-Singer protocol; and C. usual care. The primary hypotheses to be tested sequentially are that: protocolized resuscitation results in lower hospital mortality than usual care (arms A & B vs. arm C) and that resuscitation targeted to achieve a normal ScvO2 (Rivers protocol) results in lower hospital mortality than fluid resuscitation and blood pressure control alone (McKendry-Singer protocol) (arm A vs. arm B). These hypotheses will be tested on all enrolled subjects following an intent-to-treat analysis. The study will enroll 1950 subjects at 19 hospitals distributed geographically throughout the US with coordination by the University of Pittsburgh. The study is powered to find a 20% RRR in mortality for both hypotheses.