Effects of evidence-based ICU care on long-term outcomes of patients with sepsis or septic shock (ILOSS): protocol for a multicentre prospective observational cohort study in Japan

Abstract

IntroductionSepsis is not only the leading cause of death in the intensive care unit (ICU) but also a major risk factor for physical and cognitive impairment and mental disorders, known as postintensive care syndrome (PICS), reduced health-related quality of life (HRQoL) and even mental health disorders in patient families (PICS-family; PICS-F). The ABCDEF bundle is strongly recommended to overcome them, while the association between implementing the bundle and the long-term outcomes is also unknown.Methods and analysisThis is a multicentre prospective observational study at 26 ICUs. All consecutive patients between 1 November 2020 and 30 April 2022, who are 18 years old or older and expected to stay in an ICU for more than 48 hours due to sepsis or septic shock, are enrolled. Follow-up to evaluate survival and PICS/ PICS-F will be performed at 3, 6 and 12 months and additionally every 6 months up to 5 years after hospital discharge. Primary outcomes include survival at 12 months, which is the primary outcome, and the incidence of PICS defined as the presence of any physical impairment, cognitive impairment or mental disorders. PICS assessment scores, HRQoL and employment status are evaluated. The association between the implementation rate for the ABCDEF bundle and for each of the individual elements and long-term outcomes will be evaluated. The PICS-F, defined as the presence of mental disorders, and HRQoL of the family is also assessed. Additional analyses with data up to 5 years follow-up are planned.Ethics and disseminationThis study received ethics approvals from Saiseikai Utsunomiya Hospital (2020-42) and all other participating institutions and was registered in the University Hospital Medical Information Network Clinical Trials Registry. Informed consent will be obtained from all patients. The findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numberUMIN000041433.

Quality of Life of Sepsis Survivors*

“…This study’s findings suggested that the QOL of patients with sepsis was lower than other critically ill patients, which was consistent with previous studies (8–14) indicating the need for attention to the QOL of patients with sepsis. Sepsis is an important risk factor for PICS, along with persistent systemic inflammation and multiple organ failure (28), because excessive inflammation after bioinvasive procedures spreads systemically, and the patient is susceptible to infections due to immunosuppression even in the subacute phase (14, 28).…”

“…PICS is the collective term for physical, cognitive, and mental dysfunction with diverse manifestations (6, 7). Symptoms associated with PICS persist for a long time after discharge from the hospital (8–10). The quality of life (QOL) of sepsis survivors who are at high risk of PICS is low (8–14) and improves only slightly over time (15).…”

“…Symptoms associated with PICS persist for a long time after discharge from the hospital (8–10). The quality of life (QOL) of sepsis survivors who are at high risk of PICS is low (8–14) and improves only slightly over time (15). However, it is unknown whether this trend is specific to sepsis survivors or all intensive care survivors.…”