UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048312 |
|---|---|
| Receipt number | R000055055 |
| Scientific Title | Long-Term Outcomes After Hospital Discharge in Critically Ill Patients-Prospective retrospective observational study- |
| Date of disclosure of the study information | 2022/07/07 |
| Last modified on | 2022/07/07 11:30:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
caf55000@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055055
