UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031093 |
|---|---|
| Receipt number | R000035448 |
| Scientific Title | Randomized controlled trials on the effectiveness of goal directed perfusion |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2020/12/15 19:38:35 |
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Basic information
Public title
Randomized controlled trials on the effectiveness of goal directed perfusion
Acronym
Randomized controlled trials on the effectiveness of goal directed perfusion
Scientific Title
Randomized controlled trials on the effectiveness of goal directed perfusion
Scientific Title:Acronym
Randomized controlled trials on the effectiveness of goal directed perfusion
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether the implementation of goal-directed perfusion suppresses postoperative acute kidney injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative acute kidney injury
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Maintain oxygen delivery during cardiopulmonary bypass is more than 300 mL/min/m2, through pump flow adjustments.
Interventions/Control_2
Conventional extracorporeal circulation management (maintain perfusion flow determined based)Perfusion will be performed at a fixed flow rate of 2.6 L/min/m2.
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
1.Subjects aged 20 years or older at the time of consent acquisition
2.Subjects undergoing open heart surgery using a heart-lung machine
3.Subjects who received sufficient explanation before participating in this study and provided written consent with sufficient understanding.
Key exclusion criteria
1.Patients with severe renal impairment (eGFR < 30 mL/min/m2)
2.Patients scheduled to undergo hypothermic extracorporeal circulation (less than 34C)
3.Patients scheduled to undergo circulatory arrest
4.Patients who have been using auxiliary circulation before surgery
5.Other patients who the principal investigator deems inappropriate as subjects
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111(3335)
saty-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo Japan
TEL
03-3813-3111(3335)
Homepage URL
saty-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
No
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
Juntendo Clinical Research and Trail Center
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo Japan
Tel
0338145672
jun-rinri@juntendo.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
順天堂大学医学部附属順天堂医院（東京都
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035448
