UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055707 |
|---|---|
| Receipt number | R000063656 |
| Scientific Title | Clinical characteristics of rehabilitation during hospitalization and activities of daily living at discharge in sepsis patients managed in the intensive care unit |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/05/15 10:03:42 |
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Basic information
Public title
Clinical characteristics of rehabilitation during hospitalization and activities of daily living at discharge in sepsis patients managed in the intensive care unit
Acronym
Characteristics of activities of daily living at discharge in sepsis patients
Scientific Title
Clinical characteristics of rehabilitation during hospitalization and activities of daily living at discharge in sepsis patients managed in the intensive care unit
Scientific Title:Acronym
Characteristics of activities of daily living at discharge in sepsis patients
Region
| Japan |
Condition
Condition
sepsis patients
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the status of inpatient rehabilitation of sepsis patients admitted to the ICU and to characterize their ADL at discharge.
2. To clarify what factors are associated with ADL at the hospital discharge in patients with sepsis.
Basic objectives2
Others
Basic objectives -Others
To identify the problems with activities of daily living in patients with sepsis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL(Barthel Index) score at hospital discharge
Key secondary outcomes
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
1. Patients admitted to the ICU with a diagnosis of sepsis or patients diagnosed with sepsis after admission to the ICU
2. Patients who have been in the ICU for more than 48 hours
3. Patients who started rehabilitation during ICU admission and continued until discharge or transfer
Key exclusion criteria
1. Patients under 18 years old
2. Patients admitted to the ICU due to head trauma, spinal cord injury, neurological disorders, or limb loss
3. Patients who have difficulty in responding to questions or following orders
4. Patients whose pre-admission ADLs were fully dependent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7963
ryokozu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kozu |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Physical Therapy Science
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7963
Homepage URL
ryokozu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Ryo Kozu
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Ethics Review Committee of the Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7726
ryokozu@nagasaki-u.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
| 2024 | Year | 11 | Month | 01 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063656
