UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015594 |
|---|---|
| Receipt number | R000018120 |
| Scientific Title | Evaluation of the effect of cardioplumonary bypass on presepsin measurement |
| Date of disclosure of the study information | 2014/11/03 |
| Last modified on | 2018/11/06 14:46:48 |
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Basic information
Public title
Evaluation of the effect of cardioplumonary bypass on presepsin measurement
Acronym
presepsin values in cardiac surgery patients
Scientific Title
Evaluation of the effect of cardioplumonary bypass on presepsin measurement
Scientific Title:Acronym
presepsin values in cardiac surgery patients
Region
| Japan |
Condition
Condition
Cardiac surgery patients
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effect of cardiopulmonary bypass on the presepsin measurement
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presepsin values in postoperative days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
cardiac surgery patients on cardiopulmonary bypass
Interventions/Control_2
Off pump coronary artery bypass grafting patients
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
cardiac surgery patients
Key exclusion criteria
Infectious sign
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Saito |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
5 Zaifu-cho, Hirosaki, Japan
TEL
0172-39-5113
fix-you@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Saito |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
5 Zaifu-cho, Hirosaki, Japan
TEL
0172-39-5113
Homepage URL
fix-you@hotmail.co.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 03 | Day |
Last modified on
| 2018 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018120
