UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033551 |
|---|---|
| Receipt number | R000038259 |
| Scientific Title | Evaluation of Continuous Sweat Lactic Acid Monitoring for Clinical Setting |
| Date of disclosure of the study information | 2018/07/28 |
| Last modified on | 2024/01/31 17:54:16 |
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Basic information
Public title
Evaluation of Continuous Sweat Lactic Acid Monitoring for Clinical Setting
Acronym
Continuous Sweat Lactic Acid Monitoring
Scientific Title
Evaluation of Continuous Sweat Lactic Acid Monitoring for Clinical Setting
Scientific Title:Acronym
Continuous Sweat Lactic Acid Monitoring
Region
| Japan |
Condition
Condition
Patients in Emergency Department
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the possibility of continuous lactic acid monitoring system in clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between sweat lactic acid and blood lactic acid
Key secondary outcomes
Relationship between sweat lactic acid and prognosis and vital signs of patients
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Case in which lactate measurement is considered necessary for usual medical treatment in Emergency department
Key exclusion criteria
1)Difficulty of continuous lactic acid monitoring, 2)Physician's policy
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Morisawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
kmori@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Morisawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
http://www.marianna-u.ac.jp/eccm/study/14297/017323.html
kmori@marianna-u.ac.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyogakubu, Daigaku Kenkyu Suishinka
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
Tel
044-977-8111
kmori@marianna-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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
http://www.marianna-u.ac.jp/eccm/office/14297/017323.html
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
| Delay expected |
Results Delay Reason
We are currently waiting for permission to use the lightweight measurement device.
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assessed continuous lactic acid in the critical patients and verified the correlation with blood lactate levels and the relevance between prognosis and vital signs.
Management information
Registered date
| 2018 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038259
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
