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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033551
Receipt No. 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 2019/01/26

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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
Middle name
Last name Kenichiro Morisawa
Organization St. Marianna University School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL 044-977-8111
Email kmori@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichiro Morisawa
Organization St. Marianna University School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL 044-977-8111
Homepage URL http://www.marianna-u.ac.jp/eccm/office/14297/017323.html
Email kmori@marianna-u.ac.jp

Sponsor
Institute Department of Emergency and Critical Care Medicine, St. Marianna University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 15 Day
Last follow-up date
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
2019 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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