TY - JOUR
T1 - Prehospital antibiotics in the ambulance for sepsis
T2 - a multicentre, open label, randomised trial
AU - Alam, Nadia
AU - Oskam, Erick
AU - PHANTASi Trial Investigators and the ORCA Research Consortium the Netherlands
AU - Stassen, Patricia M.
AU - Exter, Pieternel van
AU - van de Ven, Peter M.
AU - Haak, H. R.
AU - Holleman, Frits
AU - Zanten, Arthur van
AU - Leeuwen-Nguyen, Hien van
AU - Bon, Victor
AU - Duineveld, Bart A.M.
AU - Panday, Rishi S.Nannan
AU - Kramer, Mark H.H.
AU - Nanayakkara, P. W.B.
AU - Alam, N.
AU - Nanayakkara, P. W.B.
AU - Oskam, E.
AU - Stassen, Patricia M.
AU - Haak, H. R.
AU - Holleman, F.
AU - Nannan Panday, R. S.
AU - Duineveld, B. A.M.
AU - van Exter, P.
AU - van de Ven, P. M.
AU - Bon, V.
AU - Goselink, J.
AU - Janssen, J.
AU - Frenken, J.
AU - Versluis, J.
AU - de Vries, G.
AU - den Boer, E.
AU - Willeboer, M.
AU - Frenken, J.
AU - Alsma, J.
AU - Slobbe, L.
AU - Wabbijn, M.
AU - van Leeuwen-Nguyen, T. T.H.
AU - Assink, J.
AU - Schouten, W. E.M.
AU - Veenstra, J.
AU - van Bokhorst, J.
AU - Govers, A.
AU - Dekker, D.
AU - Verhoeven, M. A.M.
AU - Kramer, M. H.H.
AU - Roest, L.
AU - Peters, E. J.G.
AU - Ang, W.
AU - Heesterman, L.
AU - Zwietering, A. N.
N1 - Acknowledgments:
We would like to thank all the patients who took part in the study.
Special thanks to the EMS personnel, emergency department health-care
workers, research staff, and all members of the ORCA (Onderzoeks
Consortium Acute Geneeskunde) Research Consortium the Netherlands
for their patience and cooperation. We are indebted to our sponsors, the
NutsOhra Foundation and the Netherlands Society of Internal Medicine
(NIV), for their support. Finally, we would also like to thank
Coen Stehouwer (Maastricht University Medical Centre, Netherlands)
and Rene van den Dorpel (Maastad Hospital Rotterdam, Netherlands)
for their intellectual input.
Publisher Copyright:© 2018 Elsevier Ltd
PY - 2018/1
Y1 - 2018/1
N2 - Background 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. Methods 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. Findings 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. Interpretation 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. Funding The NutsOhra Foundation, Netherlands Society of Internal Medicine (NIV).
AB - Background 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. Methods 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. Findings 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. Interpretation 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. Funding The NutsOhra Foundation, Netherlands Society of Internal Medicine (NIV).
UR - http://www.scopus.com/inward/record.url?scp=85036532901&partnerID=8YFLogxK
U2 - 10.1016/S2213-2600(17)30469-1
DO - 10.1016/S2213-2600(17)30469-1
M3 - Article
C2 - 29196046
AN - SCOPUS:85036532901
SN - 2213-2600
VL - 6
SP - 40
EP - 50
JO - The Lancet Respiratory Medicine
JF - The Lancet Respiratory Medicine
IS - 1
ER -