UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028864 |
|---|---|
| Receipt number | R000032808 |
| Scientific Title | Effect of neuromuscular electrical stimulation in patients with sepsis |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/02/29 12:01:33 |
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Basic information
Public title
Effect of neuromuscular electrical stimulation in patients with sepsis
Acronym
Neuromuscular electrical stimulation in patients with sepsis
Scientific Title
Effect of neuromuscular electrical stimulation in patients with sepsis
Scientific Title:Acronym
Neuromuscular electrical stimulation in patients with sepsis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of neuromuscular electrical stimulation in patients with sepsis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main outcome is the mobility ability. The measurement is performed at ICU admission and discharge, and before hospital discharge. Difference in the mobility ability between patients with neuromuscular electrical stimulation and those without historical control.
Key secondary outcomes
Secondary outcome is the muscle strength and activity of daily living. The measurement is performed at ICU admission and discharge, and before hospital discharge. Difference in the muscle strength and activity of daily living between patients with neuromuscular electrical stimulation and those without historical control.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Muscle strength training with neuromuscular electrical stimulation is performed for 60-min each day, 5-days per week, from the patients or proxies agreement to hospital discharge.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with sepsis in admission to medical intensive care unit at our single hospital.
2. Patients were followed in rehabilitation
3. Participants or proxies agreed to join this research.
Key exclusion criteria
1. Unable to walk without assistance before ICU admission
2. Neuromuscular disease (e.g. myasthenia Gravis, Guillain-Barre disease)
3. Muscle inflammation (e.g. rhabdomyolysis, myositis, neuroleptic malignant syndrome)
4. Skin lesions (e.g. burns)
5. Patients who were determined inappropriate to rehabilitation because of declining clinical status.
6. Patients who were determined inappropriate to participate in this study by attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miho Shimizu |
Organization
Nagoya University Hospital
Division name
Department of Rehabilitation
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
miho.shimizu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Nakajima |
Organization
Nagoya University Hospital
Division name
Department of Rehabilitation
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
Homepage URL
nkjmx1121@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
