UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032617 |
|---|---|
| Receipt number | R000037194 |
| Scientific Title | The dynamics and pathophysiological function of endothelial microparticles in sepsis. |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2023/11/19 20:53:24 |
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Basic information
Public title
The dynamics and pathophysiological function of endothelial microparticles in sepsis.
Acronym
Endothelial Microparticles in Sepsis
Scientific Title
The dynamics and pathophysiological function of endothelial microparticles in sepsis.
Scientific Title:Acronym
Endothelial Microparticles in Sepsis
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the dynamics and pathophysiological action of endothelial microparticles ins sepsis
Basic objectives2
Others
Basic objectives -Others
To elucidate the correlation between circulating endothelial microparticles in patients with sepsis and the severity of sepsis or organ failures.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of circulating EMPs during ICU
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
Adult patients with sepsis who are admitted into the intensive care unit in Tohoku University Hospital.
Key exclusion criteria
failure to obtain informed consent
infection with unknown onset
supported by ECMO (extracorporeal membrane oxygenation)
the initiation of renal replacement therapy before the entry
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Takei |
Organization
Tohoku University Hospital
Division name
The department of Anesthesiology
Zip code
980-8574
Address
2-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL
022-717-7321
ytakei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takei |
Organization
Tohoku University Hospital
Division name
The division of anesthesiology
Zip code
980-8574
Address
2-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL
022-717-7321
Homepage URL
ytakei@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-1-172
Org. issuing International ID_1
Tohoku University Graduate 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
| 2020 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037194
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037194
Number of participants that the trial has enrolled
102
Results
ThePECAM+ or VE-cadherin+ EDEVs on admission was significantly higher in the septic-shock group than the sepsis group (p = 0.043 or 0.004). Furthermore, multivariable analysis revealed that the numbers of PECAM+ and VE-cadherin+ EDEVs were independently higher in the septic-shock group than in the sepsis group.
The abundance of all types was significantly higher in the sepsis and septic-shock groups compared with the non-sepsis group.
Results date posted
| 2021 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30 sepsis patients, 42 septic-shock patients, 30 non-sepsis patients
Participant flow
Septic patients were those who were diagnosed with sepsis and admitted to the ICU, and were enrolled in the study after obtaining consent from themselves or their next of kin. Non-septic patients were those undergoing scheduled head and neck surgery, and consent for participation in the study was obtained during the preoperative visit. Blood samples were collected at admission and on days 2, 3, and 5 of admission to purify platelet poor plasma. EDEVs in the plasma s
Adverse events
No adverse events.
Outcome measures
Number of PECAM+EDEVs, VE-cadhein+EDEVs, E-selectin+EDEVs, ICAM-1+EDEVs, VCAM-1+EDEVs in plasma samples.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The number of circulating EMPs with PECAM, VE-cadherin, E-selectin, ICAM-1 or VCAM-1.
Management information
Registered date
| 2018 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037194
