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

Keibun Liu, Toru Kotani, Kensuke Nakamura, Takai Chihiro, Yasunari Morita, Kenzo Ishii, Kenji Fujizuka, Daisetsu Yasumura, Daisuke Taniguchi, Tomohiro Hamagami, Nobutake Shimojo, Masakazu Nitta, Takashi Hongo, Kazuki Akieda, Maeda Atsuo, Tadashi Kaneko, Yutaka Sakuda, Kohkichi Andoh, Akiyoshi Nagatomi, Yukiko TanakaYuhei Irie, Hiroshi Kamijo, Manabu Hanazawa, Daisuke Kasugai, Matsuoka Ayaka, Kenji Oike, Alan Kawarai Lefor, Kunihiko Takahashi, Hajime Katsukawa, Takayuki Ogura

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)e054478
JournalBMJ Open
Issue number3
Publication statusPublished - Mar 28 2022


  • Adult intensive & critical care
  • Anxiety disorders
  • Delirium & cognitive disorders
  • Depression & mood disorders
  • Epidemiology

ASJC Scopus subject areas

  • General Medicine


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