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
Alan Kawarai Lefor,
Takayuki Ogura,
Kunihiko Takahashi,
Kensuke Nakamura,
Toru Kotani,
Daisuke Taniguchi,
Daisuke Kasugai,
Keibun Liu,
Yasunari Morita,
Kenji Fujizuka,
Takai Chihiro,
Kenzo Ishii,
Daisetsu Yasumura,
Tomohiro Hamagami,
Nobutake Shimojo,
Masakazu Nitta,
Takashi Hongo,
Kazuki Akieda,
Maeda Atsuo,
Tadashi Kaneko,
Yutaka Sakuda,
Kohkichi Andoh,
Akiyoshi Nagatomi,
Yukiko Tanaka,
Yuhei Irie,
Hiroshi Kamijo,
Manabu Hanazawa,
Matsuoka Ayaka,
Kenji Oike,
Hajime Katsukawa
Affiliations
Alan Kawarai Lefor
Department of Surgery, Jichi Medical University, Shimotsuke, Japan
Takayuki Ogura
Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan
Kunihiko Takahashi
Department of Biostatistics, M&D Data Science Center, Tokyo Medical and Dental University, Tokyo, Japan
Kensuke Nakamura
Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Japan
Toru Kotani
Department of Intensive Care Medicine, Showa University, Tokyo, Japan
Daisuke Taniguchi
Neurology, Juntendo Univerity Faculty of Medicine, Tokyo, Japan
Daisuke Kasugai
Department of Emergency and Critical Care Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan
Keibun Liu
Critical Care Research Group, The Prince Charles Hospital, Brisbane, Queensland, Australia
Yasunari Morita
Department of Critical Care Medicine, Nagoya Medical Center, Nagoya, Japan
Kenji Fujizuka
Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Maebashi, Japan
Takai Chihiro
Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan
Kenzo Ishii
Department of Anesthesiology, Intensive Care Unit, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan
Daisetsu Yasumura
Department of Rehabilitation, Naha City Hospital, Naha, Okinawa, Japan
Tomohiro Hamagami
Tajima Emergency & Critical Care Medical Center, Toyooka Public Hospital, Toyooka, Japan
Nobutake Shimojo
Emergency and Critical Care Medicine, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan
Masakazu Nitta
Department of Intensive Care Unit, Niigata University Medical and Dental Hospital, Niigata, Niigata, Japan
Takashi Hongo
Emergency Department, Okayama Saiseikai General Hospital, Okayama, Japan
Kazuki Akieda
Department of Emergency Medicine, SUBARU Health Insurance Society Ota Memorial Hospital, Ota, Japan
Maeda Atsuo
Department of Emergency and Disaster Medicine, Showa University Fujigaoka Hospital, Yokohama, Kanagawa, Japan
Tadashi Kaneko
Emergency and Critical Care Center, Mie University Hospital, Tsu, Mie, Japan
Yutaka Sakuda
Department of Intensive Care Medicine, Okinawa Kyodo Hospital, Naha, Okinawa, Japan
Kohkichi Andoh
Division of Anesthesiology, Sendai City Hospital, Sendai, Miyagi, Japan
Akiyoshi Nagatomi
Department of Emergency medicine and Critical Care, St. Marianna University School of Medicine, Yokohama-City Seibu Hospital, Yokohama, Japan
Yukiko Tanaka
Department of emergency, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan
Yuhei Irie
Department of Emergency and Critical care medicine, Fukuoka University Hospital, Fukuoka, Japan
Hiroshi Kamijo
Intensive Care Unit, Shinshu University Hospital, Matsumoto, Nagano, Japan
Manabu Hanazawa
Department of Rehabilitation, Japan Red Cross Narita Hospital, Narita, Japan
Matsuoka Ayaka
Department of Emergency and Critical Care Medicine Faculty, Saga University Hospital, Saga, Saga, Japan
Kenji Oike
Department of Rehabilitation, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan
Hajime Katsukawa
Japanese Society for Early Mobilization, Tokyo, Japan
Introduction Sepsis 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 analysis This 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 dissemination This 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 number UMIN000041433.
