Prehospital antibiotics in the ambulance for sepsis: a multicentre, open label, randomised trial
Nadia Alam, Erick Oskam, Patricia M Stassen, et al.
Lancet Respir Med 2017 Published: 28 November 2017
DOI: http://dx.doi.org/10.1016/S2213-2600(17)30469-1
Summary
Background 背景
Emergency medical services (EMS) personnel have already made substantial contributions to improving care for patients with time-dependent illnesses, such as trauma and myocardial infarction. Patients with sepsis could also benefit from timely prehospital care.
医疗急救系统(EMS)的医务人员已经尽其所能,改进时间依赖性疾病如创伤或心肌梗塞患者的治疗。全身性感染患者也可能获益于及时的院前治疗。
Methods 方法
After training EMS personnel in recognising sepsis, we did a randomised controlled open-label trial in ten large regional ambulance services serving 34 secondary and tertiary care hospitals in the Netherlands. We compared the effects of early administration of antibiotics in the ambulance with usual care. Eligible patients were randomly assigned (1:1) using block-randomisation with blocks of size 4 to the intervention (open-label intravenous ceftriaxone 2000 mg in addition to usual care) or usual care (fluid resuscitation and supplementary oxygen). Randomisation was stratified per region. The primary outcome was all-cause mortality at 28 days and analysis was by intention to treat. To assess the effect of training, we determined the average time to antibiotics (TTA) in the emergency department and recognition of sepsis by EMS personnel before and after training. The trial is registered at ClinicalTrials.gov, number NCT01988428.
对EMS医务人员进行了识别全身性感染的相关培训后,我们在荷兰的10个大型地区性急救中心(服务于34所二级及三级医院)进行了一项随机对照开放标签试验。我们比较了在救护车内早期给予抗生素与常规治疗的效果。我们采用区组随机(区组大小为4),将入选患者按照1:1的比例随机分为干预组(除常规治疗外,开放标签静脉输注头孢曲松2000 mg)或常规治疗组(液体复苏及氧疗)。根据地区进行分层随机。主要预后指标为28天全因病死率,采用意向治疗分析方法。为评价培训的作用,我们确定了在急诊科应用抗生素的平均时间(TTA),以及EMS医务人员在培训前后识别全身性感染的时间。研究在ClinicalTrials.gov注册,注册号NCT01988428。
Findings 结果
2698 patients were enrolled between June 30, 2014, and June 26, 2016. 2672 patients were included in the intention-to-treat analysis: 1535 in the intervention group and 1137 in the usual care group. The intervention group received antibiotics a median of 26 min (IQR 19–34) before arriving at the emergency department. In the usual care group, median TTA after arriving at the emergency department was 70 min (IQR 36–128), compared with 93 min (IQR 39–140) before EMS personnel training (p=0·142). At day 28, 120 (8%) patients had died in the intervention group and 93 (8%) had died in the usual care group (relative risk 0·95, 95% CI 0·74–1·24). 102 (7%) patients in the intervention group and 119 (10%) in the usual care group were re-admitted to hospital within 28 days (p=0·0004). Seven mild allergic reactions occurred, none of which could be attributed to ceftriaxone.
2004年6月30日至2016年6月25日期间,我们共入选2698名患者;其中2672名患者纳入意向治疗分析:干预组1535名,常规治疗组1137名。干预组患者在到达急诊科前26分钟(IQR 19–34)接受了抗生素治疗。在常规治疗组,TTA中位数为到达急诊科后 70 分钟 (IQR 36–128),而培训前为 93 分钟 (IQR 39–140) (p=0·142)。至第28天时,干预组 120 名患者 (8%) 死亡,常规治疗组 93 名患者(8%) 死亡(相对危险度 0·95, 95% CI 0·74–1·24)。干预组 102 名患者 (7%) 及常规治疗组 119 (10%) 名患者在28天内再次入院 (p=0·0004)。发生7例轻度过敏反应,均与头孢曲松无关。
Interpretation 结论
In patients with varying severity of sepsis, EMS personnel training improved early recognition and care in the whole acute care chain. However, giving antibiotics in the ambulance did not lead to improved survival, regardless of illness severity.
对于严重程度不同的全身性感染患者,针对EMS医务人员的培训能够改进早期识别及治疗。然而,在救护车中给予抗生素不能改善生存率。
Funding
The NutsOhra Foundation, Netherlands Society of Internal Medicine (NIV).