Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059649) titled 'Neuroimaging and post-intensive care syndrome of septic patients' on Nov. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Wakayama Mediccal University
Condition:
Condition - sepsis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 15
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067016
Disclaimer: Curated by HT Syndication.