UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043276
Receipt number R000049397
Scientific Title effect of microcirculation during cardiac surgery
Date of disclosure of the study information 2021/02/08
Last modified on 2021/02/08 12:49:21

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Basic information

Public title

effect of microcirculation during cardiac surgery

Acronym

effect of microcirculation during cardiac surgery

Scientific Title

effect of microcirculation during cardiac surgery

Scientific Title:Acronym

effect of microcirculation during cardiac surgery

Region

Japan


Condition

Condition

cardiac surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the endothelial glycocalyx of microcirculation to the surgical procedure for cardiac surgery.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of microcirculation during surgery

Key secondary outcomes

Relationship between perioperative data and microcirculation


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

Patients who require surgical operation using cardiopulmonary bypass or transcatheter surgery for heart disease

Key exclusion criteria

Patients who have had previous heart surgery
Emergency surgery
Patients with left ventricular ejection fraction of 40% or less
Patients with insulin-dependent diabetes mellitus
Dialysis patient
Patients with BMI of 35 or more
Patients who need circulatory arrest during cardiopulmonary bypass

Target sample size

36


Research contact person

Name of lead principal investigator

1st name takashi
Middle name
Last name kobayashi

Organization

Iwate Medical University

Division name

Anesthesiology

Zip code

028-3695

Address

2-1-1 Idaidoorinityoume Yahaba-tyou, Iwate, Japan

TEL

019-651-7111

Email

takakoba@iwate-med.ac.jp


Public contact

Name of contact person

1st name takashi
Middle name
Last name kobayashi

Organization

Iwate Medical University

Division name

Anesthesiology

Zip code

028-3695

Address

2-1-1 Idaidoori Yahaba-tyou, Iwate, Japan

TEL

019-651-7111

Homepage URL


Email

takakoba@iwate-med.ac.jp


Sponsor or person

Institute

Iwate Medical University

Institute

Department

Personal name



Funding Source

Organization

Iwate Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iwate Medical University

Address

2-1-1 Idaidoori Yahaba-tyou, Iwate 028-3695, Japan

Tel

019-651-7111

Email

takakoba@iwate-med.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



Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 08 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

Open public recruiting

Date of protocol fixation

2019 Year 02 Month 01 Day

Date of IRB

2020 Year 02 Month 25 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2023 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

microcirculation


Management information

Registered date

2021 Year 02 Month 08 Day

Last modified on

2021 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049397


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name