UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049622 |
|---|---|
| Receipt number | R000056272 |
| Scientific Title | Evaluation of the efficacy of neuromuscular electrical stimulation in ICU patients undergoing continuous renal replacement therapy. |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2024/11/28 09:04:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the efficacy of neuromuscular electrical stimulation in ICU patients undergoing continuous renal replacement therapy.
Acronym
Evaluation of the efficacy of neuromuscular electrical stimulation in ICU patients undergoing continuous renal replacement therapy.
Scientific Title
Evaluation of the efficacy of neuromuscular electrical stimulation in ICU patients undergoing continuous renal replacement therapy.
Scientific Title:Acronym
Evaluation of the efficacy of neuromuscular electrical stimulation in ICU patients undergoing continuous renal replacement therapy.
Region
| Japan |
Condition
Condition
Acute renal failure
Classification by specialty
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of early neuromuscular electrical stimulation on quantitative and qualitative changes in muscle, physical function and physical, mental and cognitive function after discharge from hospital in patients undergoing continuous renal replacement therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quadriceps muscle thickness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rehabilitation is based on NMES and early mobilization and rehabilitation protocols.
NMES is performed on both lower limb muscles for 30 minutes per day, at least five times per week, until the day of ICU discharge.
Interventions/Control_2
Rehabilitation is based on NMES and early mobilization and rehabilitation protocols.
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
Patients admitted to ICU and receiving continuous renal replacement therapy
Key exclusion criteria
(i) Difficulty in standing prior to ICU admission.
(ii) Use of intra-aortic balloon pumping
(iii) Circulatory support by percutaneous cardiopulmonary support
(iv) Pacemaker placement (NMES group only) (v) Skin injury at the electrode site (NMES group only)
(5) Skin injury at the electrode site (NMES group only)
(vi) Presence of deep vein thrombosis (NMES group only)
(vii) Other patients deemed unsuitable as research subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tadayoshi |
| Middle name | |
| Last name | Nonoyama |
Organization
University of Fukui Hospital
Division name
Department of Rehabilitation
Zip code
9101193
Address
23-3, Matsuoka-Shimogozuki, Eiheiji-machi, Yoshida-gun, Fukui.
TEL
0776-61-3111
nonoyama@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tadayoshi |
| Middle name | |
| Last name | Nonoyama |
Organization
University of Fukui Hospital
Division name
Department of Rehabilitation
Zip code
9101193
Address
23-3, Matsuoka-Shimogozuki, Eiheiji-machi, Yoshida-gun, Fukui.
TEL
0776-61-3111
Homepage URL
nonoyama@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Fukui Hospital
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
University of Fukui Hospital
Address
23-3, Matsuoka-Shimogozuki, Eiheiji-machi, Yoshida-gun, Fukui.
Tel
0776-61-3111
nonoyama@u-fukui.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
| 2022 | Year | 11 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056272
