UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062485 |
|---|---|
| Receipt number | R000071517 |
| Scientific Title | Establishment of an Early Detection Method and Validation of Predictive Performance for Intensive Care Unit-Acquired Weakness (ICUAW) |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/05 20:11:17 |
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Basic information
Public title
Establishment of an Early Detection Method and Validation of Predictive Performance for Intensive Care Unit-Acquired Weakness (ICUAW)
Acronym
Establishment of an Early Detection Method and Validation of Predictive Performance for Intensive Care Unit-Acquired Weakness (ICUAW)
Scientific Title
Establishment of an Early Detection Method and Validation of Predictive Performance for Intensive Care Unit-Acquired Weakness (ICUAW)
Scientific Title:Acronym
Establishment of an Early Detection Method and Validation of Predictive Performance for Intensive Care Unit-Acquired Weakness (ICUAW)
Region
| Japan |
Condition
Condition
Intensive Care Unit-Acquired Weakness (ICUAW)
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to measure movement-related potential (MRP) amplitude and excitation-contraction coupling time (ECCT) during the early phase of intensive care unit (ICU) admission (within 7 days) in critically ill patients and to clarify the association between these electrophysiological parameters and the subsequent development of intensive care unit-acquired weakness (ICUAW). Furthermore, this study will evaluate whether MRP amplitude and ECCT obtained during the early ICU stay can discriminate patients who subsequently develop ICUAW, thereby assessing their utility as bedside tools for the early detection of ICUAW.
The rationale for this study is that, although ICUAW has a substantial impact on the prognosis of critically ill patients, objective diagnosis during the early phase of ICU admission remains challenging using currently available clinical assessment methods alone. By employing a non-invasive and relatively simple electrophysiological approach, this study may facilitate the early identification of the pathophysiological changes associated with ICUAW and support timely clinical decision-making regarding early intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Movement-related potential (MRP) amplitude and excitation-contraction coupling time (ECCT)
Key secondary outcomes
Compound muscle action potential amplitude
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Nerve conduction studies and MRP/ECCT measurements using a piezoelectric sensor during the early phase of ICU stay (within 7 days of ICU admission)
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 who meet all of the following criteria will be eligible for enrollment:
Patients admitted to the ICU at Sapporo Medical University Hospital
Patients aged 18 years or older
Patients in whom the study measurements can be performed early after ICU admission (within 7 days)
Patients (or their legally acceptable representative) who have provided written informed consent for participation in this study
Key exclusion criteria
Patients who meet any of the following criteria will not be eligible for enrollment:
Patients judged to have significant confounding of ICUAW assessment due to pre-existing neuromuscular disease, spinal cord disease, or severe central nervous system impairment
Patients in whom appropriate testing is difficult due to skin disorders, trauma, infection, or other conditions at the measurement muscle or stimulation site
Patients in whom the specified measurements are difficult to perform due to limb amputation, marked contracture, or other reasons
Patients judged unsuitable for study participation by the principal investigator, sub-investigator, or attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Hisahara |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Neurology
Zip code
060-8556
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
neurol@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Bungo |
| Middle name | |
| Last name | Hirose |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Neurology
Zip code
060-8556
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
bungo1026@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
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
Research Support Division, Sapporo Medical University
Address
South 1, West 17, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@ml.sapmed.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
| 2026 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071517
