Shapiro Nathan I, Howell Michael D, Talmor Daniel, Lahey Dermot, Ngo Long, Buras Jon, Wolfe Richard E, Weiss J Woodrow, Lisbon Alan
Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Crit Care Med. 2006 Apr;34(4):1025-32. doi: 10.1097/01.CCM.0000206104.18647.A8.
To describe the effectiveness of a comprehensive, interdisciplinary sepsis treatment protocol with regard to both implementation and outcomes and to compare the mortality rates and therapies of patients with septic shock with similar historical controls.
Prospective, interventional cohort study with a historical control comparison group.
Urban, tertiary care, university hospital with 46,000 emergency department visits and 4,100 intensive care unit admissions annually.
Inclusion criteria were a) emergency department patients aged > or =18 yrs, b) suspected infection, and c) lactate of >4 mmol/L or septic shock. Exclusion criteria were a) emergent operation, b) prehospital cardiac arrest, and c) comfort measures only. Time period: protocol, November 10, 2003, through November 9, 2004; historical controls, February 1, 2000, through January 31, 2001.
A sepsis treatment pathway incorporating empirical antibiotics, early goal-directed therapy, drotrecogin alfa, steroids, intensive insulin therapy, and lung-protective ventilation.
There were 116 protocol patients, with a mortality rate of 18% (11-25%), of which 79 patients had septic shock. Comparing these patients with 51 historical controls, protocol patients received more fluid (4.0 vs. 2.5 L crystalloid, p < .001), earlier antibiotics (90 vs. 120 mins, p < .013), more appropriate empirical coverage (97% vs. 88%, p < .05), more vasopressors in the first 6 hrs (80% vs. 45%, p < .001), tighter glucose control (mean morning glucose, 123 vs. 140, p < .001), and more frequent assessment of adrenal function (82% vs. 10%, p < .001), with a nonstatistically significant increase in dobutamine use (14% vs. 4%, p = .06) and red blood cell transfusions (30% vs. 18%, p = .07) in the first 24 hrs. For protocol patients with septic shock, 28-day in-hospital mortality was 20.3% compared with 29.4% for historical controls (p = .3).
Clinical implementation of a comprehensive sepsis treatment protocol is feasible and is associated with changes in therapies such as time to antibiotics, intravenous fluid delivery, and vasopressor use in the first 6 hrs. No statistically significant decrease in mortality was demonstrated, as this trial was not sufficiently powered to assess mortality benefits.
描述一项综合、多学科的脓毒症治疗方案在实施和治疗结果方面的有效性,并将感染性休克患者的死亡率和治疗方法与类似的历史对照进行比较。
设有历史对照比较组的前瞻性干预队列研究。
一所城市三级医疗大学医院,每年有46,000人次急诊就诊和4,100人次重症监护病房收治。
纳入标准为:a)年龄≥18岁的急诊科患者;b)疑似感染;c)乳酸水平>4 mmol/L或感染性休克。排除标准为:a)急诊手术;b)院前心脏骤停;c)仅采取姑息治疗措施。时间段:方案实施期为2003年11月10日至2004年11月9日;历史对照期为2000年2月1日至2001年1月31日。
采用包含经验性抗生素、早期目标导向治疗、重组人活化蛋白C、类固醇、强化胰岛素治疗和肺保护性通气的脓毒症治疗路径。
有116例方案组患者,死亡率为18%(11%-25%),其中79例为感染性休克患者。将这些患者与51例历史对照患者比较,方案组患者接受了更多的液体(晶体液4.0 L对2.5 L,p<.001)、更早使用抗生素(90分钟对120分钟,p<.013)、更恰当的经验性覆盖(97%对88%,p<.05)、在最初6小时内使用更多血管升压药(80%对45%,p<.001)、更严格的血糖控制(早晨平均血糖,123对140,p<.001)以及更频繁地评估肾上腺功能(82%对10%,p<.001),在最初24小时内多巴酚丁胺使用量(14%对4%,p = .06)和红细胞输注量(30%对18%,p = .07)有非统计学意义的增加。对于方案组感染性休克患者,28天院内死亡率为20.3%,而历史对照患者为29.4%(p = .3)。
综合脓毒症治疗方案的临床实施是可行的,并且与治疗方法的改变相关,如抗生素使用时间、静脉输液量以及最初6小时内血管升压药的使用。未显示出死亡率有统计学意义的降低,因为该试验的样本量不足以评估死亡率获益。