Sandra L Peake1, Anthony Delaney2, Michael Bailey3, Rinaldo Bellomo4. 1. University of Adelaide and The Queen Elizabeth Hospital, Adelaide, South Australia; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. Electronic address: sandra.peake@sa.gov.au. 2. Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Royal North Shore Hospital and University of Sydney, Sydney, New South Wales, Australia. 3. Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. 4. Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Austin Hospital, Melbourne, Victoria, Australia.
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.
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.
Authors: Massimo Sartelli; Yoram Kluger; Luca Ansaloni; Timothy C Hardcastle; Jordi Rello; Richard R Watkins; Matteo Bassetti; Eleni Giamarellou; Federico Coccolini; Fikri M Abu-Zidan; Abdulrashid K Adesunkanmi; Goran Augustin; Gian L Baiocchi; Miklosh Bala; Oussema Baraket; Marcelo A Beltran; Asri Che Jusoh; Zaza Demetrashvili; Belinda De Simone; Hamilton P de Souza; Yunfeng Cui; R Justin Davies; Sameer Dhingra; Jose J Diaz; Salomone Di Saverio; Agron Dogjani; Mutasim M Elmangory; Mushira A Enani; Paula Ferrada; Gustavo P Fraga; Sabrina Frattima; Wagih Ghnnam; Carlos A Gomes; Souha S Kanj; Aleksandar Karamarkovic; Jakub Kenig; Faryal Khamis; Vladimir Khokha; Kaoru Koike; Kenneth Y Y Kok; Arda Isik; Francesco M Labricciosa; Rifat Latifi; Jae G Lee; Andrey Litvin; Gustavo M Machain; Ramiro Manzano-Nunez; Piotr Major; Sanjay Marwah; Michael McFarlane; Ziad A Memish; Cristian Mesina; Ernest E Moore; Frederick A Moore; Noel Naidoo; Ionut Negoi; Richard Ofori-Asenso; Iyiade Olaoye; Carlos A Ordoñez; Mouaqit Ouadii; Ciro Paolillo; Edoardo Picetti; Tadeja Pintar; Alfredo Ponce-de-Leon; Guntars Pupelis; Tarcisio Reis; Boris Sakakushev; Hossein Samadi Kafil; Norio Sato; Jay N Shah; Boonying Siribumrungwong; Peep Talving; Cristian Tranà; Jan Ulrych; Kuo-Ching Yuan; Fausto Catena Journal: World J Emerg Surg Date: 2018-01-25 Impact factor: 5.469