Potential Impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on Future Sepsis Research

Peake, Sandra; Bailey, Michael; Bellomo, Rinaldo; Bennett, Victoria; Board, Jasmin; McCracken, Phoebe; McGloughlin, Steven; Nanjayya, Vinodh Bhagyalakshmi; Teo, Adrian; Hill, Edward J.; Jones, Philip H.; O’Brien, Emily C.; Sawtell, F.; Schimanski, K; Wilson, Darius Cameron; Bolch, S.; Eastwood, Glenn M; Kerr, Fergus; Peak, L.; Young, H. Patrick; Edington, John; Fletcher, Jason; Ghelani, Dhaval; Nand, Kiran; Sara, Treena; Cross, Anthony; Flemming, D; Grummisch, M.; Purdue, A.; Fulton, Emily; Grove, Kristen; Harney, Allison; Milburn, K.; Millar, Rebecca T; Mitchell, Imogen; Rodgers, Helen; Scanlon, Samantha A; Coles, Theresa; Connor, H.; Dennett, Jennifer; Berkel, Anouk van; Barrington-Onslow, S.; Henderson, Susan; Mehrtens, Jan; Dryburgh, J.; Tankel, A.; Braitberg, George; O’Bree, B.; Shepherd, K; Vij, Sanjiv; Allsop, Steve; Haji, Darsim; Haji, Kavi; Vuat, J.; Bone, Augusta Lissette Díaz; Elderkin, Tania; Orford, Neil; Ragg, Michael; Kelly, Sally; Stewart, David; Woodward, Neil W.; Harjola, Veli‐Pekka; Okkonen, Marjatta; Pettilä, Ville; Sutinen, S.; Wilkman, Erika; Fratzia, J.; Halkhoree, J.; Treloar, Susan A.; Ryan, Kimberley; Sandford, T.; Walsham, James; Jenkins, Carly; Williamson, David; Burrows, Jason; Hawkins, D. F.; Tang, Chenxi; Dimakis, A.; Holdgate, Anna; Micallef, Sharon; Parr, Michael; White, Hayden; Morrison, Laurie J.; Sosnowski, Kellie; Ramadoss, Rajaram; Soar, Natalie; Wood, James H.; Franks, Michael; Williams, A.P.; Hogan, Cainnear K; Song, Renjie; Tilsley, Anna; Rainsford, D.; Wells, Richard A.; Dowling, J. Thomas; Galt, Pauline; Lamac, Tammy; Lightfoot, Dr.Timothy; Walker, Craig; Braid, K.; DeVillecourt, T.; Tan, Hongzhuan; Seppelt, Ian; Chang, Le; Cheung, WS; Fok, S.K.; Lam, Phirun; Lam, Sin‐Man; So, Hietala; Yan, Wei; Altea, A.; Lancashire, Bill; Gomersall, Charles D; Graham, C A; Leung, Patricia; Arora, Subhash; Bass, Frances; Shehabi, Yahya; Isoardi, Jonathon; Isoardi, Katherine Z; Powrie, DJ; Lawrence, Sarah; Ankor, A.; Chester, L.; Davies, M.; O’Connor, Stephanie N.; Poole, Andrew E.; Soulsby, Tom; Sundararajan, Krishnaswamy; Williams, Julian; Greenslade, Jaimi; MacIsaac, Christopher; Gorman, Kristen F.; Jordan, Ashby; Moore, Linda W.; Ankers, S.; Bird, Shawn J.; Delaney, Anthony; Fogg, Toby; Hickson, E.; Jewell, T.; Kyneur, K.; O’Connor, Anne; Townsend, Jennifer; Yarad, Elizabeth; Brown, Samuel M.; Chamberlain, Jenny; Cooper, Jamie D.; Jenkinson, Emma; McDonald, Ellen; Webb, Steven A R; Buhr, H. J.; Coakley, J.; Cowell, Jessica; Hutch, Debra; Gattas, David; Keir, M.; Rajbhandari, Dorrilyn; Rees, CJ; Baker, Sarah F; Roberts, Brian W.; Farone, E.; Holmes, James H.; Santamaria, John; Winter, Cathy; Finckh, Axel; Knowles, Serena; McCabe, John B.; Nair, Priya; Reynolds, Claire; Ahmed, Behairy Amira Abdel Azeem; Barton, D; Meaney, Edel; Nichol, Alistair; Harris, Rhodri; Shields, Lynn; Thomas, Karl W.; Karlsson, Sari; Kuitunen, Anne; Kukkurainen, Atte; Tenhunen, Jyrki; Varila, Simo; Ryan, N. Thomas; Trethewy, Christopher; Crosdale, J.; Smith, Jeffrey C.; Vellaichamy, M.; Furyk, Jeremy; Gordon, Gilad; Jones, Llewelyn; Senthuran, Siva; Bates, Samantha; Butler, John M.; French, Craig; Tippett, Ashley; Kelly, Justin; Kwans, J.; Murphy, Michael; O'Flynn, David; Kurenda, Catherine; Otto, Tobias; Raniga, V.; Williams, Patricia J.; Ho, Heng-Tsan; Leung, Ann N.; Wu, Haiya

doi:10.1016/j.annemergmed.2017.04.007

Cited by 21 publications

(11 citation statements)

References 11 publications

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“…Since the qSOFA score was developed, many people have evaluated its clinical value for sepsis. Some articles reported that the qSOFA as a good prognostic predictor [25,33], whereas other studies found that the qSOFA may not be an adequate screening tool in the ED because of its poor sensitivity [34][35][36]. A recent meta-analysis showed that the qSOFA was better than the SIRS was in predicting in-hospital mortality of sepsis [37], and a similar finding was observed in our cohort.…”

Section: Discussionsupporting

confidence: 82%

Prognostic accuracy of SIRS criteria and qSOFA score for in-hospital mortality among influenza patients in the emergency department

Chu

Seak

et al. 2020

BMC Infect Dis

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Background: The seasonal influenza epidemic is an important public health issue worldwide. Early predictive identification of patients with potentially worse outcome is important in the emergency department (ED). Similarly as with bacterial infection, influenza can cause sepsis. This study was conducted to investigate the effectiveness of the Systemic Inflammatory Response Syndrome (SIRS) criteria and the quick Sequential Organ Failure Assessment (qSOFA) score as prognostic predictors for ED patients with influenza. Methods: This single-center, retrospective cohort study investigated data that was retrieved from a hospital-based research database. Adult ED patients (age ≥ 18 at admission) with laboratory-proven influenza from 2010 to 2016 were included for data analysis. The initial SIRS and qSOFA scores were both collected. The primary outcome was the utility of each score in the prediction of in-hospital mortality. Results: For the study period, 3561 patients met the study inclusion criteria. The overall in-hospital mortality was 2.7% (95 patients). When the qSOFA scores were 0, 1, 2, and 3, the percentages of in-hospital mortality were 0.6, 7.2, 15.9, and 25%, respectively. Accordingly, the odds ratios (ORs) were 7.72, 11.92, and 22.46, respectively. The sensitivity and specificity was 24 and 96.2%, respectively, when the qSOFA score was ≥2. However, the SIRS criteria showed no significant associations with the primary outcome. The area under the receiver operating characteristic curve (AUC) was 0.864, which is significantly higher than that with SIRS, where the AUC was 0.786 (P < 0.01). Conclusions: The qSOFA score potentially is a useful prognostic predictor for influenza and could be applied in the ED as a risk stratification tool. However, qSOFA may not be a good screening tool for triage because of its poor sensitivity. The SIRS criteria showed poor predictive performance in influenza for mortality as an outcome. Further research is needed to determine the role of these predictive tools in influenza and in other viral infections.

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Section: Discussionsupporting

confidence: 82%

Prognostic accuracy of SIRS criteria and qSOFA score for in-hospital mortality among influenza patients in the emergency department

Chu

Seak

et al. 2020

BMC Infect Dis

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“…The remaining 103 were discussed in a consensus meeting by CAG, MB, KH, LL, and RL. We included 45 papers in the final analysis [15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59] (Figure 1). Excluded studies and the reasons for their exclusion are listed in Appendix G (Table A1).…”

Section: Resultsmentioning

confidence: 99%

qSOFA is a Poor Predictor of Short-Term Mortality in All Patients: A Systematic Review of 410,000 Patients

Leung

Brabrand

et al. 2019

JCM

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Background: To determine the validity of the Quick Sepsis-Related Organ Failure Assessment (qSOFA) in the prediction of outcome (in-hospital and 1-month mortality, intensive care unit (ICU) admission, and hospital and ICU length of stay) in adult patients with or without suspected infections where qSOFA was calculated and reported; Methods: Cochrane Central of Controlled trials, EMBASE, BIOSIS, OVID MEDLINE, OVID Nursing Database, and the Joanna Briggs Institute EBP Database were the main databases searched. All studies published until 12 April 2018 were considered. All studies except case series, case reports, and conference abstracts were considered. Studies that included patients with neutropenic fever exclusively were excluded. Results: The median AUROC for in-hospital mortality (27 studies with 380,920 patients) was 0.68 (a range of 0.55 to 0.82). A meta-analysis of 377,623 subjects showed a polled AUROC of 0.68 (0.65 to 0.71); however, it also confirmed high heterogeneity among studies (I2 = 98.8%, 95%CI 98.6 to 99.0). The median sensitivity and specificity for in-hospital mortality (24 studies with 118,051 patients) was 0.52 (range 0.16 to 0.98) and 0.81 (0.19 to 0.97), respectively. Median positive and negative predictive values were 0.2 (range 0.07 to 0.38) and 0.94 (0.85 to 0.99), respectively.

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“…Although a number of post hoc analyses of randomized controlled trials and registry data report mortality rates greater than 40% when Sepsis-3 criteria are applied, [8][9][10] other data sets have also found lower than predicted mortality rates when applying the Sepsis-3 criteria. [11][12][13] The mortality rates for day 90 were comparable between the ADRENAL-APROCCHSS cohort and the original APROCCHSS cohort, although there was no different treatment effect between hydrocortisone and placebo in the ADRENAL. The other major difference between the ADRENAL and APROCCHSS was the use of fludrocortisone in the latter.…”

Section: Discussionmentioning

confidence: 99%

Hydrocortisone Compared with Placebo in Patients with Septic Shock Satisfying the Sepsis-3 Diagnostic Criteria and APROCCHSS Study Inclusion Criteria

et al. 2019

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Background: Two recent randomized controlled trials (Adjunctive Glucocorticoid Therapy in Patients with Septic Shock [ADRENAL] and Activated Protein C and Corticosteroids for Human Septic Shock [APROCCHSS]) of corticosteroids in patients with septic shock reported different treatment effects on 90-day mortality. Both trials enrolled patients who met the criteria for septic shock using the second international consensus definitions for sepsis and septic shock (Sepsis-2), but the APROCCHSS trial mandated a greater severity of shock as an inclusion criterion. Methods: The authors conducted post hoc sensitivity analyses of the ADRENAL trial to determine the effects of hydrocortisone versus placebo in subgroups selected using third international consensus definitions for sepsis and septic shock (Sepsis-3) diagnostic criteria or APROCCHSS inclusion criteria. results: There were 1,950 subjects (973 hydrocortisone and 977 placebo) who met the Sepsis-3 criteria (ADRENAL-Sepsis-3 cohort) and 905 patients (455 hydrocortisone and 450 placebo) who met the APROCCHSS criteria (ADRENAL-APROCCHSS cohort). At 90 days after randomization, in the ADRENAL-Sepsis-3 cohort, 312 of 963 (32.4%) and 337 of 958 (35.2%) patients assigned to hydrocortisone and placebo, respectively, had died (odds ratio, 0.86; 95% CI, 0.70 to 1.06; P = 0.166). The corresponding figures for the ADRENAL-APROCCHSS cohorts were 187 of 453 (41.3%) and 200 of 445 (44.9%), respectively (odds ratio, 0.84; 95% CI, 0.60 to 1.17; P = 0.303). There was no statistically significant difference in the time to death between the groups during the 90 days after randomization (hazard ratio = 0.87; 95% CI, 0.75 to 1.02; P = 0.082 for ADRENAL-Sepsis-3; and hazard ratio = 0.86; 95% CI, 0.71 to 1.06; P = 0.156 for ADRENAL-APROCCHSS cohorts). In both cohorts, patients assigned to hydrocortisone had faster resolution of shock. In the ADRENAL-Sepsis-3 cohort, patients assigned to hydrocortisone had an increase in the number of days alive and free of mechanical ventilation (57.0 ± 37.2 vs. 53.7 ± 38.2 days; 95% CI, 0.40 to 7.04; P = 0.028) and the number of days alive and free of the intensive care unit (54.3 ± 36.0 vs. 51.0 ± 37.1; 95% CI, 0.82 to 7.24; P = 0.014). Conclusions: In a post hoc analysis of the ADRENAL trial participants who fulfilled either the Sepsis-3 or the APROCCHSS inclusion criteria, a continuous infusion of hydrocortisone did not result in a lower 90-day mortality than placebo in septic shock.

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Potential Impact of the 2016 Consensus Definitions of Sepsis and Septic Shock on Future Sepsis Research

Cited by 21 publications

References 11 publications

Prognostic accuracy of SIRS criteria and qSOFA score for in-hospital mortality among influenza patients in the emergency department

Prognostic accuracy of SIRS criteria and qSOFA score for in-hospital mortality among influenza patients in the emergency department

qSOFA is a Poor Predictor of Short-Term Mortality in All Patients: A Systematic Review of 410,000 Patients

Hydrocortisone Compared with Placebo in Patients with Septic Shock Satisfying the Sepsis-3 Diagnostic Criteria and APROCCHSS Study Inclusion Criteria

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