UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059649 |
|---|---|
| Receipt number | R000067016 |
| Scientific Title | Neuroimaging and post-intensive care syndrome of septic patients |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 17:24:04 |
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Basic information
Public title
Neuroimaging and post-intensive care syndrome of septic patients
Acronym
Neuro-PICS
Scientific Title
Neuroimaging and post-intensive care syndrome of septic patients
Scientific Title:Acronym
Neuro-PICS
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To longitudinally evaluate brain MRI findings and the severity of post-intensive care syndrome (PICS) in patients with sepsis, to identify structural brain changes associated with the development and progression of PICS
Basic objectives2
Others
Basic objectives -Others
To explore blood biomarkers related to these brain alterations
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PICS symptoms at 3 months and 1 year after ICU discharge (QOL, cognitive function, anxiety/depressive symptoms, PTSD symptoms, ADL), and brain MRI findings including microbleeds, atrophy, and white matter lesions.
Key secondary outcomes
Serum levels of IL-6, IL-8, IL-10, TNF-alpha, CRP, S100b, NSE, and neurofilament light chain
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with sepsis based on Sepsis-3 criteria who underwent brain MRI due to impaired consciousness
ICU stay of 48 hours or longer
Expected to achieve independent or minimally assisted daily living through rehabilitation after discharge or transfer, with the ability to attend outpatient follow-up
Key exclusion criteria
* Patients who died during hospitalization
* Patients with a history of dementia or psychiatric disorders (those receiving medication or diagnosed at a medical institution)
* Patients unable to ambulate during hospitalization and therefore unable to attend outpatient visits
* Patients discharged to long-term care facilities and unable to attend outpatient visits
* Patients transferred to chronic care hospitals and unable to attend outpatient visits
* Patients whose primary diagnosis at admission could affect consciousness
* Patients with a pre-admission Barthel Index of 60 or lower
* Patients for whom MRI examination may be harmful due to implanted medical devices, internal/external metal objects, tattoos, or claustrophobia
* Patients otherwise unable to attend outpatient visits for any reason
* Patients deemed inappropriate for inclusion by the attending physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Nozomu |
| Middle name | |
| Last name | Shima |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, Japan
TEL
073-441-0603
nozowmu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Shima |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, Japan
TEL
073-441-0603
Homepage URL
nozowmu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Mediccal University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama-City, Wakayama-Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing special
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067016
