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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name