UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025990 |
|---|---|
| Receipt number | R000029735 |
| Scientific Title | The role of criculating endothelial microparticles in ARDS |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2017/02/03 14:22:03 |
* 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
The role of criculating endothelial microparticles in ARDS
Acronym
The role of criculating endothelial microparticles in ARDS
Scientific Title
The role of criculating endothelial microparticles in ARDS
Scientific Title:Acronym
The role of criculating endothelial microparticles in ARDS
Region
| Japan |
Condition
Condition
ARDS, sepsis, septic shock
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to investigate the effectiveness of endothelial microparticles as a biomarker to ARDS by analyzing the subtype of endothelial microparticles from ARDS patients.
Basic objectives2
Others
Basic objectives -Others
The basic objectives of this study is to investigate the differences in the endothelial microaprticles between ARDS patients and not ARDS patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of endothelial microparticles and subtype of endothelial microparticles from sepsis patients who were managed in the ICU of Tohoku University Hospital
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with sepsis or septic shock
Key exclusion criteria
the patients on whom it passed more than one week since infectious onset
the patients with ECMO or mechanical circulatory supports
the patients with dialysis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Saito |
Organization
Tohoku University Hospital
Division name
The department of Intensive Care Medicine
Zip code
Address
Seiryo-machi 1-1, Aoba-ku Sendai-shi, Miyagi 980-8574 JAPAN
TEL
022-717-7406
K2saito40@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takei Yusuke |
Organization
Tohoku University School of Medicine
Division name
The department of Anesthesiology and periopreative medicine
Zip code
Address
Seiryo-machi 1-1, Aoba-ku Sendai-shi, Miyagi 980-8574 JAPAN
TEL
022-717-7406
Homepage URL
yusuke.takei.e8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Sciences and Technology Agency
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2015-1-279
Org. issuing International ID_1
Tohoku University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endothelial microparticles are measured from serum specimens of sepsis patients by flow cytometer and examined for differences in the presence or absence of ARDS onset.
Management information
Registered date
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029735
