Potential impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on future sepsis research

Sandra L. Peake, A. Delaney, Michael Bailey, Rinaldo Bellomo, ARISE Investigators, V. Bennett, J. Board, P. McCracken, S. McGloughlin, V. Nanjayya, A. Teo, E. Hill, P. Jones, E. O'Brien, F. Sawtell, K. Schimanski, D. Wilson, S. Bolch, G. Eastwood, F. Kerr & 192 others L. Peak, H. Young, J. Edington, J. Fletcher, J. Smith, D. Ghelani, K. Nand, T. Sara, A. Cross, D. Flemming, M. Grummisch, A. Purdue, E. Fulton, K. Grove, A. Harney, K. Milburn, R. Millar, I. Mitchell, H. Rodgers, S. Scanlon, T. Coles, H. Connor, J. Dennett, A. Van Berkel, S. Barrington-Onslow, S. Henderson, J. Mehrtens, J. Dryburgh, A. Tankel, G. Braitberg, B. O'Bree, K. Shepherd, S. Vij, S. Allsop, D. Haji, K. Haji, J. Vuat, A. Bone, T. Elderkin, N. Orford, M. Ragg, S. Kelly, D. Stewart, N. Woodward, V. P. Harjola, M. Okkonen, V. Pettilä, S. Sutinen, E. Wilkman, J. Fratzia, J. Halkhoree, S. Treloar, K. Ryan, T. Sandford, J. Walsham, C. Jenkins, D. Williamson, J. Burrows, D. Hawkins, C. Tang, A. Dimakis, A. Holdgate, S. Micallef, M. Parr, H. White, L. Morrison, K. Sosnowski, R. Ramadoss, N. Soar, J. Wood, M. Franks, A. Williams, C. Hogan, R. Song, A. Tilsley, D. Rainsford, N. Soar, R. Wells, J. Wood, J. Dowling, P. Galt, T. Lamac, D. Lightfoot, C. Walker, K. Braid, T. DeVillecourt, H. S. Tan, I. Seppelt, L. F. Chang, W. S. Cheung, S. K. Fok, P. K. Lam, S. M. Lam, H. M. So, W. W. Yan, A. Altea, B. Lancashire, C. D. Gomersall, C. A. Graham, P. Leung, S. Arora, F. Bass, Y. Shehabi, J. Isoardi, K. Isoardi, D. Powrie, S. Lawrence, A. Ankor, L. Chester, M. Davies, S. O'Connor, A. Poole, T. Soulsby, K. Sundararajan, J. Williams, J. H. Greenslade, C. MacIsaac, K. Gorman, A. Jordan, L. Moore, S. Ankers, S. Bird, J. Dowling, T. Fogg, E. Hickson, T. Jewell, K. Kyneur, A. O'Connor, J. Townsend, E. Yarad, S. Brown, J. Chamberlain, J. Cooper, E. Jenkinson, E. McDonald, S. Webb, H. Buhr, J. Coakley, J. Cowell, D. Hutch, D. Gattas, M. Keir, D. Rajbhandari, C. Rees, S. Baker, B. Roberts, E. Farone, J. Holmes, J. Santamaria, C. Winter, A. Finckh, S. Knowles, J. McCabe, P. Nair, C. Reynolds, B. Ahmed, D. Barton, E. Meaney, A. Nichol, R. Harris, L. Shields, K. Thomas, S. Karlsson, A. Kuitunen, A. Kukkurainen, J. Tenhunen, S. Varila, J. Burrows, N. Ryan, C. Trethewy, J. Crosdale, J. C. Smith, M. Vellaichamy, J. Furyk, G. Gordon, L. Jones, S. Senthuran, S. Bates, J. Butler, C. French, A. Tippett, J. Kelly, J. Kwans, M. Murphy, D. O'Flynn, C. Kurenda, T. Otto, V. Raniga, P. Williams, H. F. Ho, A. Leung, H. Wu

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Study objective: The influence of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) on the conduct of future sepsis research is unknown. We seek to examine the potential effect of the new definitions on the identification and outcomes of patients enrolled in a sepsis trial. Methods: This was a post hoc analysis of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial of early goal-directed therapy that recruited 1,591 adult patients presenting to the emergency department (ED) with early septic shock diagnosed by greater than or equal to 2 systemic inflammatory response syndrome criteria and either refractory hypotension or hyperlactatemia. The proportion of participants who would have met the Sepsis-3 criteria for quick Sequential Organ Failure Assessment (qSOFA) score, sepsis (an increased Sequential Organ Failure Assessment score ≥2 because of infection) and septic shock before randomization, their baseline characteristics, interventions delivered, and mortality were determined. Results: There were 1,139 participants who had a qSOFA score of greater than or equal to 2 at baseline (71.6% [95% confidence interval {CI} 69.4% to 73.8%]). In contrast, 1,347 participants (84.7% [95% CI 82.9% to 86.4%]) met the Sepsis-3 criteria for sepsis. Only 1,010 participants were both qSOFA positive and met the Sepsis-3 criteria for sepsis (63.5% [95% CI 61.1% to 65.8%]). The Sepsis-3 definition for septic shock was met at baseline by 203 participants (12.8% [95% CI 11.2% to 14.5%]), of whom 175 (86.2% [95% CI 81.5% to 91.0%]) were also qSOFA positive. Ninety-day mortality for participants fulfilling the Sepsis-3 criteria for sepsis and septic shock was 20.4% (95% CI 18.2% to 22.5%) (274/1,344) and 29.6% (95% CI 23.3% to 35.8% [60/203]) versus 9.4% (95% CI 5.8% to 13.1%) (23/244) and 17.1% (95% CI 15.1% to 19.1% [237/1,388]), respectively, for participants not meeting the criteria (risk differences 11.0% [95% CI 6.2% to 14.8%] and 12.5% [95% CI 6.3% to 19.4%], respectively). Conclusion: Most ARISE participants did not meet the Sepsis-3 definition for septic shock at baseline. However, the majority fulfilled the new sepsis definition and mortality was higher than for participants not fulfilling the criteria. A quarter of participants meeting the new sepsis definition did not fulfill the qSOFA screening criteria, potentially limiting its utility as a screening tool for sepsis trials with patients with suspected infection in the ED. The implications of the new definitions for patients not eligible for recruitment into the ARISE trial are unknown.

LanguageEnglish
Pages553-561.e1
Number of pages9
JournalAnnals of emergency medicine
Volume70
Issue number4
DOIs
Publication statusPublished - 1 Oct 2017

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Septic Shock
Sepsis
Research
Confidence Intervals
Organ Dysfunction Scores
Resuscitation
Mortality
Hospital Emergency Service
Systemic Inflammatory Response Syndrome

Cite this

Peake, Sandra L. ; Delaney, A. ; Bailey, Michael ; Bellomo, Rinaldo ; ARISE Investigators. / Potential impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on future sepsis research. In: Annals of emergency medicine. 2017 ; Vol. 70, No. 4. pp. 553-561.e1.
@article{fb5efc2569ea47c096fa87c0a207b512,
title = "Potential impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on future sepsis research",
abstract = "Study objective: The influence of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) on the conduct of future sepsis research is unknown. We seek to examine the potential effect of the new definitions on the identification and outcomes of patients enrolled in a sepsis trial. Methods: This was a post hoc analysis of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial of early goal-directed therapy that recruited 1,591 adult patients presenting to the emergency department (ED) with early septic shock diagnosed by greater than or equal to 2 systemic inflammatory response syndrome criteria and either refractory hypotension or hyperlactatemia. The proportion of participants who would have met the Sepsis-3 criteria for quick Sequential Organ Failure Assessment (qSOFA) score, sepsis (an increased Sequential Organ Failure Assessment score ≥2 because of infection) and septic shock before randomization, their baseline characteristics, interventions delivered, and mortality were determined. Results: There were 1,139 participants who had a qSOFA score of greater than or equal to 2 at baseline (71.6{\%} [95{\%} confidence interval {CI} 69.4{\%} to 73.8{\%}]). In contrast, 1,347 participants (84.7{\%} [95{\%} CI 82.9{\%} to 86.4{\%}]) met the Sepsis-3 criteria for sepsis. Only 1,010 participants were both qSOFA positive and met the Sepsis-3 criteria for sepsis (63.5{\%} [95{\%} CI 61.1{\%} to 65.8{\%}]). The Sepsis-3 definition for septic shock was met at baseline by 203 participants (12.8{\%} [95{\%} CI 11.2{\%} to 14.5{\%}]), of whom 175 (86.2{\%} [95{\%} CI 81.5{\%} to 91.0{\%}]) were also qSOFA positive. Ninety-day mortality for participants fulfilling the Sepsis-3 criteria for sepsis and septic shock was 20.4{\%} (95{\%} CI 18.2{\%} to 22.5{\%}) (274/1,344) and 29.6{\%} (95{\%} CI 23.3{\%} to 35.8{\%} [60/203]) versus 9.4{\%} (95{\%} CI 5.8{\%} to 13.1{\%}) (23/244) and 17.1{\%} (95{\%} CI 15.1{\%} to 19.1{\%} [237/1,388]), respectively, for participants not meeting the criteria (risk differences 11.0{\%} [95{\%} CI 6.2{\%} to 14.8{\%}] and 12.5{\%} [95{\%} CI 6.3{\%} to 19.4{\%}], respectively). Conclusion: Most ARISE participants did not meet the Sepsis-3 definition for septic shock at baseline. However, the majority fulfilled the new sepsis definition and mortality was higher than for participants not fulfilling the criteria. A quarter of participants meeting the new sepsis definition did not fulfill the qSOFA screening criteria, potentially limiting its utility as a screening tool for sepsis trials with patients with suspected infection in the ED. The implications of the new definitions for patients not eligible for recruitment into the ARISE trial are unknown.",
author = "Peake, {Sandra L.} and A. Delaney and Michael Bailey and Rinaldo Bellomo and {ARISE Investigators} and V. Bennett and J. Board and P. McCracken and S. McGloughlin and V. Nanjayya and A. Teo and E. Hill and P. Jones and E. O'Brien and F. Sawtell and K. Schimanski and D. Wilson and S. Bolch and G. Eastwood and F. Kerr and L. Peak and H. Young and J. Edington and J. Fletcher and J. Smith and D. Ghelani and K. Nand and T. Sara and A. Cross and D. Flemming and M. Grummisch and A. Purdue and E. Fulton and K. Grove and A. Harney and K. Milburn and R. Millar and I. Mitchell and H. Rodgers and S. Scanlon and T. Coles and H. Connor and J. Dennett and {Van Berkel}, A. and S. Barrington-Onslow and S. Henderson and J. Mehrtens and J. Dryburgh and A. Tankel and G. Braitberg and B. O'Bree and K. Shepherd and S. Vij and S. Allsop and D. Haji and K. Haji and J. Vuat and A. Bone and T. Elderkin and N. Orford and M. Ragg and S. Kelly and D. Stewart and N. Woodward and Harjola, {V. P.} and M. Okkonen and V. Pettil{\"a} and S. Sutinen and E. Wilkman and J. Fratzia and J. Halkhoree and S. Treloar and K. Ryan and T. Sandford and J. Walsham and C. Jenkins and D. Williamson and J. Burrows and D. Hawkins and C. Tang and A. Dimakis and A. Holdgate and S. Micallef and M. Parr and H. White and L. Morrison and K. Sosnowski and R. Ramadoss and N. Soar and J. Wood and M. Franks and A. Williams and C. Hogan and R. Song and A. Tilsley and D. Rainsford and N. Soar and R. Wells and J. Wood and J. Dowling and P. Galt and T. Lamac and D. Lightfoot and C. Walker and K. Braid and T. DeVillecourt and Tan, {H. S.} and I. Seppelt and Chang, {L. F.} and Cheung, {W. S.} and Fok, {S. K.} and Lam, {P. K.} and Lam, {S. M.} and So, {H. M.} and Yan, {W. W.} and A. Altea and B. Lancashire and Gomersall, {C. D.} and Graham, {C. A.} and P. Leung and S. Arora and F. Bass and Y. Shehabi and J. Isoardi and K. Isoardi and D. Powrie and S. Lawrence and A. Ankor and L. Chester and M. Davies and S. O'Connor and A. Poole and T. Soulsby and K. Sundararajan and J. Williams and Greenslade, {J. H.} and C. MacIsaac and K. Gorman and A. Jordan and L. Moore and S. Ankers and S. Bird and J. Dowling and T. Fogg and E. Hickson and T. Jewell and K. Kyneur and A. O'Connor and J. Townsend and E. Yarad and S. Brown and J. Chamberlain and J. Cooper and E. Jenkinson and E. McDonald and S. Webb and H. Buhr and J. Coakley and J. Cowell and D. Hutch and D. Gattas and M. Keir and D. Rajbhandari and C. Rees and S. Baker and B. Roberts and E. Farone and J. Holmes and J. Santamaria and C. Winter and A. Finckh and S. Knowles and J. McCabe and P. Nair and C. Reynolds and B. Ahmed and D. Barton and E. Meaney and A. Nichol and R. Harris and L. Shields and K. Thomas and S. Karlsson and A. Kuitunen and A. Kukkurainen and J. Tenhunen and S. Varila and J. Burrows and N. Ryan and C. Trethewy and J. Crosdale and Smith, {J. C.} and M. Vellaichamy and J. Furyk and G. Gordon and L. Jones and S. Senthuran and S. Bates and J. Butler and C. French and A. Tippett and J. Kelly and J. Kwans and M. Murphy and D. O'Flynn and C. Kurenda and T. Otto and V. Raniga and P. Williams and Ho, {H. F.} and A. Leung and H. Wu",
year = "2017",
month = "10",
day = "1",
doi = "10.1016/j.annemergmed.2017.04.007",
language = "English",
volume = "70",
pages = "553--561.e1",
journal = "Annals of emergency medicine",
issn = "0196-0644",
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}

Potential impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on future sepsis research. / Peake, Sandra L.; Delaney, A.; Bailey, Michael; Bellomo, Rinaldo; ARISE Investigators.

In: Annals of emergency medicine, Vol. 70, No. 4, 01.10.2017, p. 553-561.e1.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Potential impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on future sepsis research

AU - Peake, Sandra L.

AU - Delaney, A.

AU - Bailey, Michael

AU - Bellomo, Rinaldo

AU - ARISE Investigators

AU - Bennett, V.

AU - Board, J.

AU - McCracken, P.

AU - McGloughlin, S.

AU - Nanjayya, V.

AU - Teo, A.

AU - Hill, E.

AU - Jones, P.

AU - O'Brien, E.

AU - Sawtell, F.

AU - Schimanski, K.

AU - Wilson, D.

AU - Bolch, S.

AU - Eastwood, G.

AU - Kerr, F.

AU - Peak, L.

AU - Young, H.

AU - Edington, J.

AU - Fletcher, J.

AU - Smith, J.

AU - Ghelani, D.

AU - Nand, K.

AU - Sara, T.

AU - Cross, A.

AU - Flemming, D.

AU - Grummisch, M.

AU - Purdue, A.

AU - Fulton, E.

AU - Grove, K.

AU - Harney, A.

AU - Milburn, K.

AU - Millar, R.

AU - Mitchell, I.

AU - Rodgers, H.

AU - Scanlon, S.

AU - Coles, T.

AU - Connor, H.

AU - Dennett, J.

AU - Van Berkel, A.

AU - Barrington-Onslow, S.

AU - Henderson, S.

AU - Mehrtens, J.

AU - Dryburgh, J.

AU - Tankel, A.

AU - Braitberg, G.

AU - O'Bree, B.

AU - Shepherd, K.

AU - Vij, S.

AU - Allsop, S.

AU - Haji, D.

AU - Haji, K.

AU - Vuat, J.

AU - Bone, A.

AU - Elderkin, T.

AU - Orford, N.

AU - Ragg, M.

AU - Kelly, S.

AU - Stewart, D.

AU - Woodward, N.

AU - Harjola, V. P.

AU - Okkonen, M.

AU - Pettilä, V.

AU - Sutinen, S.

AU - Wilkman, E.

AU - Fratzia, J.

AU - Halkhoree, J.

AU - Treloar, S.

AU - Ryan, K.

AU - Sandford, T.

AU - Walsham, J.

AU - Jenkins, C.

AU - Williamson, D.

AU - Burrows, J.

AU - Hawkins, D.

AU - Tang, C.

AU - Dimakis, A.

AU - Holdgate, A.

AU - Micallef, S.

AU - Parr, M.

AU - White, H.

AU - Morrison, L.

AU - Sosnowski, K.

AU - Ramadoss, R.

AU - Soar, N.

AU - Wood, J.

AU - Franks, M.

AU - Williams, A.

AU - Hogan, C.

AU - Song, R.

AU - Tilsley, A.

AU - Rainsford, D.

AU - Soar, N.

AU - Wells, R.

AU - Wood, J.

AU - Dowling, J.

AU - Galt, P.

AU - Lamac, T.

AU - Lightfoot, D.

AU - Walker, C.

AU - Braid, K.

AU - DeVillecourt, T.

AU - Tan, H. S.

AU - Seppelt, I.

AU - Chang, L. F.

AU - Cheung, W. S.

AU - Fok, S. K.

AU - Lam, P. K.

AU - Lam, S. M.

AU - So, H. M.

AU - Yan, W. W.

AU - Altea, A.

AU - Lancashire, B.

AU - Gomersall, C. D.

AU - Graham, C. A.

AU - Leung, P.

AU - Arora, S.

AU - Bass, F.

AU - Shehabi, Y.

AU - Isoardi, J.

AU - Isoardi, K.

AU - Powrie, D.

AU - Lawrence, S.

AU - Ankor, A.

AU - Chester, L.

AU - Davies, M.

AU - O'Connor, S.

AU - Poole, A.

AU - Soulsby, T.

AU - Sundararajan, K.

AU - Williams, J.

AU - Greenslade, J. H.

AU - MacIsaac, C.

AU - Gorman, K.

AU - Jordan, A.

AU - Moore, L.

AU - Ankers, S.

AU - Bird, S.

AU - Dowling, J.

AU - Fogg, T.

AU - Hickson, E.

AU - Jewell, T.

AU - Kyneur, K.

AU - O'Connor, A.

AU - Townsend, J.

AU - Yarad, E.

AU - Brown, S.

AU - Chamberlain, J.

AU - Cooper, J.

AU - Jenkinson, E.

AU - McDonald, E.

AU - Webb, S.

AU - Buhr, H.

AU - Coakley, J.

AU - Cowell, J.

AU - Hutch, D.

AU - Gattas, D.

AU - Keir, M.

AU - Rajbhandari, D.

AU - Rees, C.

AU - Baker, S.

AU - Roberts, B.

AU - Farone, E.

AU - Holmes, J.

AU - Santamaria, J.

AU - Winter, C.

AU - Finckh, A.

AU - Knowles, S.

AU - McCabe, J.

AU - Nair, P.

AU - Reynolds, C.

AU - Ahmed, B.

AU - Barton, D.

AU - Meaney, E.

AU - Nichol, A.

AU - Harris, R.

AU - Shields, L.

AU - Thomas, K.

AU - Karlsson, S.

AU - Kuitunen, A.

AU - Kukkurainen, A.

AU - Tenhunen, J.

AU - Varila, S.

AU - Burrows, J.

AU - Ryan, N.

AU - Trethewy, C.

AU - Crosdale, J.

AU - Smith, J. C.

AU - Vellaichamy, M.

AU - Furyk, J.

AU - Gordon, G.

AU - Jones, L.

AU - Senthuran, S.

AU - Bates, S.

AU - Butler, J.

AU - French, C.

AU - Tippett, A.

AU - Kelly, J.

AU - Kwans, J.

AU - Murphy, M.

AU - O'Flynn, D.

AU - Kurenda, C.

AU - Otto, T.

AU - Raniga, V.

AU - Williams, P.

AU - Ho, H. F.

AU - Leung, A.

AU - Wu, H.

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Study objective: The influence of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) on the conduct of future sepsis research is unknown. We seek to examine the potential effect of the new definitions on the identification and outcomes of patients enrolled in a sepsis trial. Methods: This was a post hoc analysis of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial of early goal-directed therapy that recruited 1,591 adult patients presenting to the emergency department (ED) with early septic shock diagnosed by greater than or equal to 2 systemic inflammatory response syndrome criteria and either refractory hypotension or hyperlactatemia. The proportion of participants who would have met the Sepsis-3 criteria for quick Sequential Organ Failure Assessment (qSOFA) score, sepsis (an increased Sequential Organ Failure Assessment score ≥2 because of infection) and septic shock before randomization, their baseline characteristics, interventions delivered, and mortality were determined. Results: There were 1,139 participants who had a qSOFA score of greater than or equal to 2 at baseline (71.6% [95% confidence interval {CI} 69.4% to 73.8%]). In contrast, 1,347 participants (84.7% [95% CI 82.9% to 86.4%]) met the Sepsis-3 criteria for sepsis. Only 1,010 participants were both qSOFA positive and met the Sepsis-3 criteria for sepsis (63.5% [95% CI 61.1% to 65.8%]). The Sepsis-3 definition for septic shock was met at baseline by 203 participants (12.8% [95% CI 11.2% to 14.5%]), of whom 175 (86.2% [95% CI 81.5% to 91.0%]) were also qSOFA positive. Ninety-day mortality for participants fulfilling the Sepsis-3 criteria for sepsis and septic shock was 20.4% (95% CI 18.2% to 22.5%) (274/1,344) and 29.6% (95% CI 23.3% to 35.8% [60/203]) versus 9.4% (95% CI 5.8% to 13.1%) (23/244) and 17.1% (95% CI 15.1% to 19.1% [237/1,388]), respectively, for participants not meeting the criteria (risk differences 11.0% [95% CI 6.2% to 14.8%] and 12.5% [95% CI 6.3% to 19.4%], respectively). Conclusion: Most ARISE participants did not meet the Sepsis-3 definition for septic shock at baseline. However, the majority fulfilled the new sepsis definition and mortality was higher than for participants not fulfilling the criteria. A quarter of participants meeting the new sepsis definition did not fulfill the qSOFA screening criteria, potentially limiting its utility as a screening tool for sepsis trials with patients with suspected infection in the ED. The implications of the new definitions for patients not eligible for recruitment into the ARISE trial are unknown.

AB - Study objective: The influence of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) on the conduct of future sepsis research is unknown. We seek to examine the potential effect of the new definitions on the identification and outcomes of patients enrolled in a sepsis trial. Methods: This was a post hoc analysis of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial of early goal-directed therapy that recruited 1,591 adult patients presenting to the emergency department (ED) with early septic shock diagnosed by greater than or equal to 2 systemic inflammatory response syndrome criteria and either refractory hypotension or hyperlactatemia. The proportion of participants who would have met the Sepsis-3 criteria for quick Sequential Organ Failure Assessment (qSOFA) score, sepsis (an increased Sequential Organ Failure Assessment score ≥2 because of infection) and septic shock before randomization, their baseline characteristics, interventions delivered, and mortality were determined. Results: There were 1,139 participants who had a qSOFA score of greater than or equal to 2 at baseline (71.6% [95% confidence interval {CI} 69.4% to 73.8%]). In contrast, 1,347 participants (84.7% [95% CI 82.9% to 86.4%]) met the Sepsis-3 criteria for sepsis. Only 1,010 participants were both qSOFA positive and met the Sepsis-3 criteria for sepsis (63.5% [95% CI 61.1% to 65.8%]). The Sepsis-3 definition for septic shock was met at baseline by 203 participants (12.8% [95% CI 11.2% to 14.5%]), of whom 175 (86.2% [95% CI 81.5% to 91.0%]) were also qSOFA positive. Ninety-day mortality for participants fulfilling the Sepsis-3 criteria for sepsis and septic shock was 20.4% (95% CI 18.2% to 22.5%) (274/1,344) and 29.6% (95% CI 23.3% to 35.8% [60/203]) versus 9.4% (95% CI 5.8% to 13.1%) (23/244) and 17.1% (95% CI 15.1% to 19.1% [237/1,388]), respectively, for participants not meeting the criteria (risk differences 11.0% [95% CI 6.2% to 14.8%] and 12.5% [95% CI 6.3% to 19.4%], respectively). Conclusion: Most ARISE participants did not meet the Sepsis-3 definition for septic shock at baseline. However, the majority fulfilled the new sepsis definition and mortality was higher than for participants not fulfilling the criteria. A quarter of participants meeting the new sepsis definition did not fulfill the qSOFA screening criteria, potentially limiting its utility as a screening tool for sepsis trials with patients with suspected infection in the ED. The implications of the new definitions for patients not eligible for recruitment into the ARISE trial are unknown.

UR - http://www.scopus.com/inward/record.url?scp=85020424121&partnerID=8YFLogxK

U2 - 10.1016/j.annemergmed.2017.04.007

DO - 10.1016/j.annemergmed.2017.04.007

M3 - Article

VL - 70

SP - 553-561.e1

JO - Annals of emergency medicine

T2 - Annals of emergency medicine

JF - Annals of emergency medicine

SN - 0196-0644

IS - 4

ER -