UMIN-CTR Clinical Trial

Basic information
Public title	Long-Term Outcomes After Hospital Discharge in Critically Ill Patients-Prospective retrospective observational study-
Acronym	J-LOCIP study
Scientific Title	Long-Term Outcomes After Hospital Discharge in Critically Ill Patients-Prospective retrospective observational study-
Scientific Title:Acronym	J-LOCIP study
Region	Japan

Condition
Condition	sepsis
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the long-term prognosis of critically ill patients in terms of mental, cognitive, and physical impairment, as well as the causal factors
Basic objectives2	Others
Basic objectives -Others	To explore causative factors of PICS based on clinical background, admission blood test findings, vital signs, and severity of illness
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Survival rate, mental impairment, cognitive impairment, and physical impairment at 3, 6, 12, 24, and 36 months after discharge
Key secondary outcomes	Causal factors of PICS (blood test findings on admission, vital signs, severity of illness, etc.)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients admitted to our emergency department or critically ill patients admitted to our emergency center or ICU, who have given consent for this study from the subject or his/her surrogate.
Key exclusion criteria	(1) Patients with cardiopulmonary arrest at the time of admission (2) Patients who do not wish to undergo aggressive treatment at the time of diagnosis at the request of the patient or his/her family (3) Patients who the principal investigator determines to be inappropriate as research subjects.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shigeaki Middle name Last name Inoue
Organization	Kobe University
Division name	School of Medicine, Dept of Disaster and Emergency Medicine
Zip code	650-0017
Address	Kusunokicho, Chuo 7-5-2, Chio-ku, Kobe, Hyogo, JAPAN
TEL	0783826521
Email	caf55000@gmail.com

Public contact
Name of contact person	1st name Shigeaki Middle name Last name Inoue
Organization	Kobe University
Division name	School of Medicine, Dept of Disaster and Emergency Medicine
Zip code	650-0017
Address	Kusunokicho, Chuo 7-5-2, Chio-ku, Kobe, Hyogo, JAPAN
TEL	0783826521
Homepage URL
Email	caf55000@gmail.com

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology Research Fund
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Ethics Committee, Graduate School of Medicine, Kobe University
Address	Kusunokicho, Chuo 7-5-2, Chio-ku, Kobe, Hyogo, JAPAN
Tel	0783826521
Email	caf55000@gmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	B210116
Org. issuing International ID_1	Medical Ethics Committee, Graduate School of Medicine, Kobe University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸大学医学部附属病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 18 Day
Date of IRB	2021 Year 09 Month 21 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry	2027 Year 03 Month 31 Day
Date trial data considered complete	2028 Year 03 Month 31 Day
Date analysis concluded	2029 Year 03 Month 31 Day

Other
Other related information	Patient information has been registered and some analysis is underway.

Management information
Registered date	2022 Year 07 Month 07 Day
Last modified on	2022 Year 07 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055055