The use of extracorporeal blood purification therapies and sequential extracorporeal support in patients with septic shock (EROICASS): a study protocol for a national, non-interventional, observational multicenter, prospective study

Silvia De Rosa1, Fiorenza Ferrari2, Massimiliano Greco3, Vincenzo Pota4, Michele Umbrello5, Antonella Cotoia6, Laura Pasin2, Federico Nalesso7, Gianluca Paternoster8, Gianluca Villa9, Sergio Lassola10, Sara Miori10, Andrea Sanna10, Vincenzo Cantaluppi11, Marita Marengo12, Fabrizio Valente13, Marco Fiorentino14, Giuliano Brunori13, Giacomo Bellani10, Antonino Giarratano14
1Centre for Medical Sciences (CISMed), University of Trento, 38122, Trento, Italy
2International Renal Research Institute of Vicenza (IRRV), Vicenza, Italy
3IRCCS Humanitas Clinical and Research Center, Milan, Italy
4Department of Woman, Child and General and Specialized Surgery, University of Campania “Luigi Vanvitelli”, Naples, Italy
5Section of Resuscitation and Anesthesia, ASST Ovest Milanese, Ospedale Nuovo Di Legnano, Legnano, Milan, Italy
6Department of Medical and Surgical Sciences, Anesthesia and Intensive Care Unit, University of Foggia, Foggia, Italy
7Nephrology, University Hospital, University of Padova, Padua, Italy
8Division of Cardiac Resuscitation, Cardiovascular Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy
9Department of Health Sciences, Intensive Care and Pain Medicine Section of Anesthesia, University of Florence, Florence, Italy
10Anaesthesia and Intensive Care, Santa Chiara Regional Hospital, APSS, Trento, Italy
11Department of Translational Medicine, Nephrology and Kidney Transplantation Unit, “Maggiore Della Carità” University Hospital, University of Piemonte Orientale (UPO), Novara, Italy
12Department of Specialist Medicine, Nephrology and Dialysis Unit, Azienda Sanitaria Locale (ASL) CN1, Cuneo, Italy
13Nephrology and Dialysis, Santa Chiara Regional Hospital, APSS, Trento, Italy
14Department of Surgical, Oncological and Oral Science (Di.Chir.On.S), University of Palermo, Palermo, Italy

Tóm tắt

Abstract Background Septic shock, a critical condition characterized by organ failure, presents a substantial mortality risk in intensive care units (ICUs), with the 28-day mortality rate possibly reaching 40%. Conventional management of septic shock typically involves the administration of antibiotics, supportive care for organ dysfunction, and, if necessary, surgical intervention to address the source of infection. In recent decades, extracorporeal blood purification therapies (EBPT) have emerged as potential interventions aimed at modulating the inflammatory response and restoring homeostasis in patients with sepsis. Likewise, sequential extracorporeal therapy in sepsis (SETS) interventions offer comprehensive organ support in the setting of multiple organ dysfunction syndrome (MODS). The EROICASS study will assess and describe the utilization of EBPT in patients with septic shock. Additionally, we will evaluate the potential association between EBPT treatment utilization and 90-day mortality in septic shock cases in Italy. Methods The EROICASS study is a national, non-interventional, multicenter observational prospective cohort study. All consecutive patients with septic shock at participating centers will be prospectively enrolled, with data collection extending from intensive care unit (ICU) admission to hospital discharge. Variables including patient demographics, clinical parameters, EBPT/SETS utilization, and outcomes will be recorded using a web-based data capture system. Statistical analyses will encompass descriptive statistics, hypothesis testing, multivariable regression models, and survival analysis to elucidate the associations between EBPT/SETS utilization and patient outcomes. Conclusions The EROICASS study provides valuable insights into the utilization and outcomes of EBPT and SETS in septic shock management. Through analysis of usage patterns and clinical data, this study aims to guide treatment decisions and enhance patient care. The implications of these findings may impact clinical guidelines, potentially improving survival rates and patient outcomes in septic shock cases.

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