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 |
* 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
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
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
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
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
