UMIN-CTR Clinical Trial

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
Institute	Iwate Medical University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049397