Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Mar 28;12(3):e054478.
doi: 10.1136/bmjopen-2021-054478.

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  1 , Toru Kotani  2 , Kensuke Nakamura  3 , Takai Chihiro  4 , Yasunari Morita  5 , Kenzo Ishii  6 , Kenji Fujizuka  7 , Daisetsu Yasumura  8 , Daisuke Taniguchi  9 , Tomohiro Hamagami  9 , Nobutake Shimojo  10 , Masakazu Nitta  11 , Takashi Hongo  12 , Kazuki Akieda  13 , Maeda Atsuo  14 , Tadashi Kaneko  15 , Yutaka Sakuda  16 , Kohkichi Andoh  17 , Akiyoshi Nagatomi  18 , Yukiko Tanaka  19 , Yuhei Irie  20 , Hiroshi Kamijo  21 , Manabu Hanazawa  22 , Daisuke Kasugai  23 , Matsuoka Ayaka  24 , Kenji Oike  25 , Alan Kawarai Lefor  26 , Kunihiko Takahashi  27 , Hajime Katsukawa  28 , Takayuki Ogura  4
Affiliations

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 et al. BMJ Open. .

Abstract

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.

Keywords: Adult intensive & critical care; Anxiety disorders; Delirium & cognitive disorders; Depression & mood disorders; Epidemiology; PAIN MANAGEMENT.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Map of participating sites.
Figure 2
Figure 2
Overview and outcome measures during follow-up. EQ-5D-5L, EuroQoL 5-dimension 5-level; IES-R, Impact of Events Scale-Revised; ICU. intensive care unit; EQ-VAS, EuroQoL Visual Analogue Scale; HADS, Hospital Anxiety and Depression.
Figure 3
Figure 3
Availability of each assessment at follow-up. EQ-5D-5L, EuroQoL 5-dimension 5-level; EQ-VAS, EuroQoL Visual Analogue Scale; HADS, Hospital Anxiety and Depression Scale; IES-R, Impact of Events Scale-Revised.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

  • One-year outcomes in sepsis: a prospective multicenter cohort study in Japan.
    Liu K, Watanabe S, Nakamura K, Nakano H, Motoki M, Kamijo H, Ayaka M, Ishii K, Morita Y, Hongo T, Shimojo N, Tanaka Y, Hanazawa M, Hamagami T, Oike K, Kasugai D, Sakuda Y, Irie Y, Nitta M, Akieda K, Shimakura D, Katsukawa H, Kotani T, McWilliams D, Nydahl P, Schaller SJ, Ogura T; ILOSS Study Group. Liu K, et al. J Intensive Care. 2025 May 1;13(1):23. doi: 10.1186/s40560-025-00792-0. J Intensive Care. 2025. PMID: 40307943 Free PMC article.

References

    1. Cecconi M, Evans L, Levy M, et al. . Sepsis and septic shock. Lancet 2018;392:75–87. 10.1016/S0140-6736(18)30696-2 - DOI - PubMed
    1. Vincent J-L, Marshall JC, Namendys-Silva SA, et al. . Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med 2014;2:380–6. 10.1016/S2213-2600(14)70061-X - DOI - PubMed
    1. Iwashyna TJ, Ely EW, Smith DM, et al. . Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA 2010;304:1787–94. 10.1001/jama.2010.1553 - DOI - PMC - PubMed
    1. Winters BD, Eberlein M, Leung J, et al. . Long-term mortality and quality of life in sepsis: a systematic review. Crit Care Med 2010;38:1276–83. 10.1097/CCM.0b013e3181d8cc1d - DOI - PubMed
    1. Nesseler N, Defontaine A, Launey Y, et al. . Long-term mortality and quality of life after septic shock: a follow-up observational study. Intensive Care Med 2013;39:881–8. 10.1007/s00134-013-2815-1 - DOI - PubMed

Publication types

Supplementary concepts

Associated data