Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial.
Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial.
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DOI：
10.1001/jama.2010.158
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发表时间：
2010-02-24
影响因子：
120.7
通讯作者：
Kline, Jeffrey A.
中科院分区：
文献类型：
--
作者：
Jones, Alan E.;Shapiro, Nathan I.;Trzeciak, Stephen;Arnold, Ryan C.;Claremont, Heather A.;Kline, Jeffrey A.
目标导向复苏严重败血症和脓毒性休克的报道，降低死亡率时，应用在急诊科。验证乳酸清除率和中心静脉氧饱和度（ScvO2）作为脓毒症早期复苏目标之间的非劣效性假设。多中心随机、非劣效性试验，纳入2007年1月至2009年1月在3家参与的美国城市医院中的1家急诊科收治的严重脓毒症和有灌注不足或脓毒性休克证据的患者。我们将患者随机分配到两种复苏方案中的一种。ScvO2组复苏至中心静脉压、平均动脉压正常化，ScvO2至少达到70%；乳酸清除率组复苏使中心静脉压、平均动脉压恢复正常，乳酸清除率至少达到10%。研究方案继续进行，直到达到所有目标或最多6小时。随后承担病人护理的临床医生对治疗任务是不知情的。主要终点是绝对住院死亡率；非劣效性阈值设为Δ = - 10%。在入选的300名患者中，每组分配150名患者，患者在人口统计学、合并症和生理特征方面匹配良好。在最初72小时的住院治疗中，治疗方法没有差异。ScvO2组34例（23%）患者在住院期间死亡（95%可信区间[CI]， 17% - 30%），而乳酸清除率组25例（17%;95% CI, 11%-24%）。观察到的死亡率差异未达到预定的- 10%阈值（意向治疗分析：6%差异的95% CI， - 3%至15%）。两组之间治疗相关不良事件没有差异。在接受中心静脉和平均动脉压正常化治疗的脓毒性休克患者中，与使ScvO2正常化治疗相比，使乳酸清除率正常化的额外治疗并没有导致院内死亡率的显著差异。
Goal-directed resuscitation for severe sepsis and septic shock has been reported to reduce mortality when applied in the emergency department. To test the hypothesis of noninferiority between lactate clearance and central venous oxygen saturation (ScvO2) as goals of early sepsis resuscitation. Multicenter randomized, noninferiority trial involving patients with severe sepsis and evidence of hypoperfusion or septic shock who were admitted to the emergency department from January 2007 to January 2009 at 1 of 3 participating US urban hospitals. We randomly assigned patients to 1 of 2 resuscitation protocols. The ScvO2 group was resuscitated to normalize central venous pressure, mean arterial pressure, and ScvO2 of at least 70%; and the lactate clearance group was resuscitated to normalize central venous pressure, mean arterial pressure, and lactate clearance of at least 10%. The study protocol was continued until all goals were achieved or for up to 6 hours. Clinicians who subsequently assumed the care of the patients were blinded to the treatment assignment. The primary outcome was absolute in-hospital mortality rate; the noninferiority threshold was set at Δ equal to −10%. Of the 300 patients enrolled, 150 were assigned to each group and patients were well matched by demographic, comorbidities, and physiological features. There were no differences in treatments administered during the initial 72 hours of hospitalization. Thirty-four patients (23%) in the ScvO2 group died while in the hospital (95% confidence interval [CI], 17%–30%) compared with 25 (17%; 95% CI, 11%–24%) in the lactate clearance group. This observed difference between mortality rates did not reach the predefined −10% threshold (intent-to-treat analysis: 95% CI for the 6% difference, −3% to 15%). There were no differences in treatment-related adverse events between the groups. Among patients with septic shock who were treated to normalize central venous and mean arterial pressure, additional management to normalize lactate clearance compared with management to normalize ScvO2 did not result in significantly different in-hospital mortality.
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影响因子：
158.5
作者：
Rivers, E;Nguyen, B;Tomlanovich, M
通讯作者：
Tomlanovich, M
DOI：
10.1186/cc6979
发表时间：
2008
期刊：
Critical care (London, England)
影响因子：
--
作者：
Perel A
通讯作者：
Perel A
影响因子：
8.8
作者：
Nguyen, HB;Rivers, EP;Tomlanovich, MC
通讯作者：
Tomlanovich, MC
影响因子：
120.7
作者：
LEGALL, JR;LEMESHOW, S;SAULNIER, F
通讯作者：
SAULNIER, F
影响因子：
8.8
作者：
Wang, Henry E.;Shapiro, Nathan I.;Yealy, Donald M.
通讯作者：
Yealy, Donald M.