UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051012 |
|---|---|
| Receipt number | R000058150 |
| Scientific Title | Relationship between myocardial temperature monitoring and postoperative cardiac dysfunction in pediatric cardiac surgery. |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/05/09 09:05:29 |
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Basic information
Public title
Relationship between myocardial temperature monitoring and postoperative cardiac dysfunction in pediatric cardiac surgery.
Acronym
Myocardial temperature in pediatric cardiac surgery
Scientific Title
Relationship between myocardial temperature monitoring and postoperative cardiac dysfunction in pediatric cardiac surgery.
Scientific Title:Acronym
Myocardial temperature in pediatric cardiac surgery
Region
| Japan |
Condition
Condition
Pediatric cardiac surgery case patients requiring cardiac arrest with cardiopulmonary bypass.
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between intraoperative myocardial temperature and postoperative cardiac dysfunction in children undergoing pediatric cardiac surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Artificial heart-lung time, artificial heart-lung machine return flow, cardiac arrest time, myocardial temperature, postoperative cardiac dysfunction markers, cardiac function assessment, in-hospital death (30 days)
Key secondary outcomes
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
| 1 | days-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with written consent obtained for all pediatric cardiac surgeries
Key exclusion criteria
Patients with hepatic or renal dysfunction, patients whose written consent could not be obtained, or patients whose cardiac temperature measuring pads were disconnected during the process.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakanishi |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
knakani@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakanishi |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
knakani@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
knakani@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Outline of the study
Relationship between intraoperative myocardial temperature and postoperative cardiac dysfunction in patients undergoing pediatric cardiac surgery in correlation with intraoperative cardiopulmonary time, ventricular return volume, cardiac arrest time, myocardial temperature, postoperative cardiac dysfunction markers, cardiac function assessment, and in-hospital death (30 days)
(2) Expected duration of subjects' participation in the study
Each subject will participate in the study for a 3-month observation period after consent.
(3) Observation and examination items
i. Basic subject information: age, sex, height, weight, diagnosis, surgical procedure
ii. Laboratory tests: blood count, biochemistry (CK, CK-MB, BNP)
iii. Cardiopulmonary device-related: ventricular duration, return flow, cardiac arrest time
iv. EF, VTI (left ventricular outflow tract) on echocardiography
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058150
