Abstract
Importance 背景
The effect of an early resuscitation protocol on sepsis outcomes in developing countries remains unknown.
早期复苏方案对发展中国家全身性感染患者预后的作用尚不清楚。
Objective 目的
To determine whether an early resuscitation protocol with administration of intravenous fluids, vasopressors, and blood transfusion decreases mortality among Zambian adults with sepsis and hypotension compared with usual care.
确定与常规治疗相比，早期复苏方案（静脉输液，升压药物及输血）能否降低赞比亚成年全身性感染及低血压患者的病死率。
Design, Setting, and Participants 设计，场景和研究人群
Randomized clinical trial of 212 adults with sepsis (suspected infection plus ≥2 systemic inflammatory response syndrome criteria) and hypotension (systolic blood pressure ≤90 mm Hg or mean arterial pressure ≤65 mm Hg) presenting to the emergency department at a 1500-bed referral hospital in Zambia between October 22, 2012, and November 11, 2013. Data collection concluded December 9, 2013.
Interventions 干预措施
Patients were randomized 1:1 to either (1) an early resuscitation protocol for sepsis (n = 107) that included intravenous fluid bolus administration with monitoring of jugular venous pressure, respiratory rate, and arterial oxygen saturation and treatment with vasopressors targeting mean arterial pressure (≥65 mm Hg) and blood transfusion (for patients with a hemoglobin level <7 g/dL) or (2) usual care (n = 105) in which treating clinicians determined hemodynamic management.
患者按照1:1被随机分为(1)全身性感染早期复苏方案组(n = 107)，包括在颈静脉压、呼吸频率和动脉血氧饱和度监测下静脉输液，采用升压药物维持平均动脉压目标 (≥65 mm Hg) 以及输血（患者Hb < 7 g/dL时），或常规治疗组(n = 105)，主治医生决定血流动力学治疗。
Main Outcomes and Measures 主要预后指标
The primary outcome was in-hospital mortality and the secondary outcomes included the volume of intravenous fluid received and receipt of vasopressors.
主要预后终点为住院病死率，次要预后终点包括静脉输液量及使用升压药物比例
Results 结果
Among 212 patients randomized to receive either the sepsis protocol or usual care, 3 were ineligible and the remaining 209 completed the study and were included in the analysis (mean [SD] age, 36.7 [12.4] years; 117 men [56.0%]; 187 [89.5%] positive for the human immunodeficiency virus). The primary outcome of in-hospital mortality occurred in 51 of 106 patients (48.1%) in the sepsis protocol group compared with 34 of 103 patients (33.0%) in the usual care group (between-group difference, 15.1% [95% CI, 2.0%-28.3%]; relative risk, 1.46 [95% CI, 1.04-2.05]; P = .03). In the 6 hours after presentation to the emergency department, patients in the sepsis protocol group received a median of 3.5 L (interquartile range, 2.7-4.0 L) of intravenous fluid compared with 2.0 L (interquartile range, 1.0-2.5 L) in the usual care group (mean difference, 1.2 L [95% CI, 1.0-1.5 L]; P < .001). Fifteen patients (14.2%) in the sepsis protocol group and 2 patients (1.9%) in the usual care group received vasopressors (between-group difference, 12.3% [95% CI, 5.1%-19.4%]; P < .001).
总共 212 名患者被随机分为全身性感染复苏方案或常规治疗组，其中3名患者不符合入选标准，其余209名患者完成研究，纳入分析（平均 [SD] 年龄 36.7 [12.4] 岁; 117 名男性 [56.0%]; 187 名 [89.5%] HIV阳性）。全身性感染复苏方案组106名患者中51名 (48.1%) 在住院期间死亡，常规治疗组103名患者中34 名 (33.0%) 死亡（组间差异，15.1% [95% CI, 2.0%-28.3%]; 相对危险度 1.46 [95% CI, 1.04-2.05]; P = .03）。急诊科就诊后6小时内，全身性感染复苏方案组患者静脉输液中位数为 3.5 L（四分位区间，2.7-4.0 L），常规治疗组为 2.0 L （四分位区间，1.0-2.5 L）（平均差异，1.2 L [95% CI, 1.0-1.5 L]; P < .001）。全身性感染复苏方案组中15名患者 (14.2%) ，常规治疗组中2名患者 (1.9%) 使用升压药物（组间差异，12.3% [95% CI, 5.1%-19.4%]; P < .001）。
Conclusions and Relevance 结论和意义
Among adults with sepsis and hypotension, most of whom were positive for HIV, in a resource-limited setting, a protocol for early resuscitation with administration of intravenous fluids and vasopressors increased in-hospital mortality compared with usual care. Further studies are needed to understand the effects of administration of intravenous fluid boluses and vasopressors in patients with sepsis across different low- and middle-income clinical settings and patient populations.
在资源有限的情况下，对于全身性感染合并低血压的成年患者（多数HIV阳性），与常规治疗相比，包括静脉输液与使用升压药物在内的早期复苏方案增加住院病死率。需要进一步研究了解静脉输液与使用升压药物对不同中低收入情况及不同患者人群全身性感染的影响。
Trial Registration
clinicaltrials.gov Identifier: NCT01663701
