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.

Autor:	Liu K; Critical Care Research Group, The Prince Charles Hospital, Brisbane, Queensland, Australia keiliu0406@gmail.com., Kotani T; Department of Intensive Care Medicine, Showa University School of Medicine, Tokyo, Japan., Nakamura K; Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan., Chihiro T; Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan., Morita Y; Department of Emergency and Intensive Care Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan., Ishii K; Department of Anesthesiology, Intensive Care Unit, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan., Fujizuka K; Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Maebashi, Japan., Yasumura D; Department of Rehabilitation, Naha City Hospital, Naha, Okinawa, Japan., Taniguchi D; Tajima Emergency & Critical Care Medical Center, Toyooka Public Hospital, Toyooka, Japan., Hamagami T; Tajima Emergency & Critical Care Medical Center, Toyooka Public Hospital, Toyooka, Japan., Shimojo N; Emergency and Critical Care Medicine, University of Tsukuba Faculty of Medicine, Tsukuba, Ibaraki, Japan., Nitta M; Department of Intensive Care Unit, Niigata University Medical and Dental Hospital, Niigata, Niigata, Japan., Hongo T; Emergency Department, Okayama Saiseikai General Hospital, Okayama, Japan., Akieda K; Department of Emergency Medicine, SUBARU Health Insurance Society Ota Memorial Hospital, Ota, Japan., Atsuo M; Department of Emergency and Disaster Medicine, Showa University Fujigaoka Hospital, Yokohama, Kanagawa, Japan., Kaneko T; Emergency and Critical Care Center, Mie University Hospital, Tsu, Mie, Japan., Sakuda Y; Department of Intensive Care Medicine, Okinawa Kyodo Hospital, Naha, Okinawa, Japan., Andoh K; Division of Anesthesiology, Sendai City Hospital, Sendai, Miyagi, Japan., Nagatomi A; Department of Emergency medicine and Critical Care, St. Marianna University School of Medicine, Yokohama-City Seibu Hospital, Yokohama, Japan., Tanaka Y; Department of emergency, Tsukuba Medical Center Hospital, Tsukuba, Ibaraki, Japan., Irie Y; Department of Emergency and Critical care medicine, Fukuoka University Hospital, Fukuoka, Japan., Kamijo H; Intensive Care Unit, Shinshu University Hospital, Matsumoto, Nagano, Japan., Hanazawa M; Department of Rehabilitation, Japan Red Cross Narita Hospital, Narita, Japan., Kasugai D; Department of Emergency and Critical Care Medicine, Nagoya University Graduate School of Medicine Faculty of Medicine, Nagoya, Aichi, Japan., Ayaka M; Department of Emergency and Critical Care Medicine Faculty, Saga University Hospital, Saga, Saga, Japan., Oike K; Department of Rehabilitation, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan., Lefor AK; Department of Surgery, Jichi Medical University, Shimotsuke, Japan., Takahashi K; M & D Data Science Center, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan., Katsukawa H; Japanese Society for Early Mobilization, Tokyo, Japan., Ogura T; Department of Emergency Medicine and Critical Care Medicine, Tochigi prefectural emergency and critical care center, Saiseikai Utsunomiya Hospital, Utsunomiya, Tochigi, Japan.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Mar 28; Vol. 12 (3), pp. e054478. Date of Electronic Publication: 2022 Mar 28.
DOI:	10.1136/bmjopen-2021-054478
Abstrakt:	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. Competing Interests: Competing interests: The authors declare that they have no competing interests for the submitted work. Some authors report potential conflicts of interest outside of this submitted study. KL reports personal fees from MERA and is the core research member of TXP Medical completely outside the submitted work. KN reports personal fees from Abbott Laboratory, Nestle, TERUMO, GETINGE, Asahi Kasei Pharma, Ono Pharmaceutical, Japan Blood Products Organisation, Nihon Pharmaceutical, Otsuka Pharmaceutical, Pfizer, Toray and Baxter, and grants from Asahi Kasei Pharma outside the submitted work. HK receives a salary from the Japanese Society for Early Mobilisation (non-profit society) as a chair (full time) outside the submitted work. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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