The optimal treatment of septic patients is still under debate. In 2001, Rivers showed that an Early Goal Directed Therapy (EGDT) was associated with improved survival and this approach was included in the 2012 Surviving Sepsis Campaign recommended bundles . In later years several studies questioned the EGDT approach, and recent studies, namely the Protocolized Care for Early Septic Shock (ProCESS) , Protocolized Management in Sepsis (ProMISE) , and Australasian Resuscitation in Sepsis Evaluation (ARISE) trials, as well as PRISM, which was the patient-level meta-analysis of those three trials, failed to confirm the survival advantage of protocolized targets for central venous pressure, Scvo2, and haemoglobin in sepsis resuscitation.
In 2016 a new sepsis definition was published: sepsis is now defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, qSOFA is proposed for early recognition, while the SOFA score has a diagnostic role. This new definition raised a lot of discussion and controversy on sensitivity and specificity of new criteria compared to previous criteria (SIRS criteria). Furthermore, the new Surviving Sepsis Campaign guidelines abandoned strict EGDS protocols, recommending less rigid resuscitation protocols guided by clinical judgment. It became clear that rapid identification and management protocols in ED and both rapid and adequate antibiotic therapy are the fundamental measures that influence outcome and mortality in sepsis.
In Italy, despite high scientific evidence and international and regional campaigns on sepsis , optimal standards of treatment are not widespread. This is due to various causes, including the difficulty of early identification of septic patients, the complexity of treatment protocols and the lack of physicians awareness of sepsis as a time-critical disease.
Since 2015 SIMEU has been promoting an educational project on sepsis that includes a Basic Course and an Advanced Course on management of septic patients. The urgent need of a project to guide our National Health Care System toward successful approaches for timely diagnosis and management of sepsis emerged from this experience.
2016 SSC guidelines are actually considered the cornerstone of treatment. Unfortunately many SSC recommendation are supported by weak scientific evidence, and are based mainly on expert opinions which could be strongly influenced by local environmental and logistic factors.
Italian Emergency Departments organization differ from those of many other western countries, and the applicability of recommendations could be strongly influenced by local factors. Thus, a specific scientific commission was established to evaluate the consensus degree and applicability of international recommendations to the specific Italian context.
In a further phase, different teams of experts will evaluate the results of this work to issue final recommendations.
The process included different phases:
- Identification of literature recommendations to be “tested” at local level (either due to the relative poor scientific evidence/ recommendation weakness or to the implementation complexity in the local organization). The statements had to be relevant for the emergency department management of the patients and were expressed to define a specific feature. Thirty-eight statements to be studied were identified.
- Identification of a panel of experts to be inserted in the Delphi process. The panel had to cover different Italian areas and included 78 sepsis experts and senior emergency physicians:
- SIMEU Sepsis Faculty members
- SIMEU National Board members
- SIMEU Regional Presidents + 2 members of each region selected by the regional president
- Compilation of a specific survey, tested by a small sample of 3-4 experts; modification of the survey following the experts’ suggestions; web upload through Survey Monkey platform.
- Delphi process: each participant received a link to the survey and had to express his/her level of agreement with the specific recommendation statement using a Likert score: from 1 (complete disagreement) to 5 (complete agreement). It was also possible to add comments and notes at the end of the survey.
- Data analysis included: % of attendance; proportional scoring of experts in agreement with the statement (scores 4 and 5); proportional scoring of experts who disagreed with the recommendation (scores 1 and 2). Recommendations that reached the 70% of agreement scores (4-5) were considered accepted, those that received ≥ 70% of disagreement (1-2) scores were considered refused. Recommendations with scores in the middle (3) will be more deeply examined in a separate phase.
- Assessment of Global Incidence and Mortality of Hospital-treated Sepsis Current Estimates and Limitations Carolin Fleischmann1,2, Andr´e Scherag3, Neill K. J. Adhikari4, Christiane S. Hartog1,2, Thomas Tsaganos5, Peter Schlattmann6, Derek C. Angus7*, and Konrad Reinhart1,2*; on behalf of the International Forum of Acute Care Trialists. Am J Respir Crit Care Med Vol 193, Iss 3, pp 259–272, Feb 1, 2016
- Sepsis in European intensive care units: Results of the SOAP study* Jean-Louis Vincent et al. Crit Care Med 2006 Vol. 34, No. 2
- Epidemiologic trends of sepsis in western countries. Alejandro Suarez De La Rica, Fernando Gilsanz, Emilio Maseda, Ann Transl Med 2016;4(17):325
- Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345(19):1368-1377
- Dellinger RP, Levy MM, Rhodes A, et al, Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock 2012, Critical Care Med. 2013, VOL. 41:580-637; Intensive Care Medicine 2013, VOL. 39:165-227.
- The ProCESS Investigators, A Randomized Trial of Protocol-Based care for early Septic Shock, The NEW ENGLAND JOURNAL of MEDICINE, May 2014, VOL. 370, NO.18,1683-1693.
- The ProMISE Trial Investigators, Trial of Early, Goal-Directed Resuscitation for Septic Shock, The NEW ENGLAND JOURNAL of MEDICINE, June 2015, VOL. 372, NO.14:1301-1311.
- The ARISE Investigators and the ANZICS Clinical Trials Group, Goal-Directed Resuscitation for Patients with Early Septic Shock, The NEW ENGLAND JOURNAL of MEDICINE, October 2014, VOL. 371, NO.16:1496-1506.
- The Sepsis Definitions Task Force Members (Singer M, Deutschman CS, et al), The Third International Consensus Definition for Sepsis and Septic Shock (Sepsis-3), Jama, February 2016,801-810.
- Andrew Rhodes et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Critical Care Medicine, March 2017 • Volume 45 • Number 3 http://journals.lww.com/ccmjournal/Abstract/publishahead/Surviving_Sepsis_Campaign International.96723.aspx
- Daniels R, Nutbeam T, McNamara G, Galvin C. The sepsis six and the severe sepsis resuscitation bundle: a prospective observational cohort study. Emerg Med J. 2011 Jun;28(6):507-12. doi: 10.1136/emj.2010.095067. Epub 2010 Oct 29
- R. Ferrer et al, Empiric Antibiotic Treatment Reduces Mortality in Severe Sepsis and Septic Shock From the First Hour: Results From a Guideline-Based Performance Improvement Program, Crit Care Med 2014; 42: 1749-1755
www.worldsepsisday.org; www.Surviving sepsis.org.guidelines; www.rcplondon.ac.uk>outputs; sepsistrust.org; www.acep.org.dart
Hsu CC, Sandford BA. The Delphi technique: Making Sense of Consensus. Practical Assessment, Research & Evaluation. 2007;12:10. http://essentialsofmedicine.com/sites/default/files/Delphi%20Technique_%20Making%20Sense%20Of%20Consensus.pdf.
- Murphy A, Wakai A, Walsh C, Cummins F, O'Sullivan R. Development of key performance indicators for prehospital emergency care. Emerg Med J. 2016 Apr;33(4):286-92. doi: 10.1136/emermed-2015-204793.
- Wakai A, O'Sullivan R, Staunton P, Walsh C, Hickey F, Plunkett PK. Development of key performance indicators for emergency departments in Ireland using an electronic modified-Delphi consensus approach. Eur J Emerg Med. 2013 Apr;20(2):109-14. doi: 10.1097/MEJ.0b013e328351e5d8.
- Madsen MM, Eiset AH, Mackenhauer J, Odby A, Christiansen CF, Kurland L, Kirkegaard H. Selection of quality indicators for hospital-based emergency care in Denmark, informed by a modified-Delphi process. Scand J Trauma Resusc Emerg Med. 2016 Feb 3;24:11. doi: 10.1186/s13049-016-0203-x