UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056090 |
|---|---|
| Receipt number | R000064093 |
| Scientific Title | Association Between Core Body Temperature and Oxygen Supply-Demand Balance During Cardiac Surgery in Children |
| Date of disclosure of the study information | 2024/11/07 |
| Last modified on | 2024/11/07 18:38:59 |
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Basic information
Public title
Association Between Core Body Temperature and Oxygen Supply-Demand Balance During Cardiac Surgery in Children
Acronym
Association Between Core Body Temperature and Oxygen Supply-Demand Balance During Cardiac Surgery in Children
Scientific Title
Association Between Core Body Temperature and Oxygen Supply-Demand Balance During Cardiac Surgery in Children
Scientific Title:Acronym
Association Between Core Body Temperature and Oxygen Supply-Demand Balance During Cardiac Surgery in Children
Region
| Japan |
Condition
Condition
Children with congenital heart disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the relationship between core body temperature and oxygen consumption, as well as the oxygen supply-demand balance, during general anesthesia in pediatric cardiac surgery patients.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to evaluate the relationship between core body temperature and oxygen consumption, as well as the oxygen supply-demand balance, during general anesthesia in pediatric cardiac surgery patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen supply-demand balance
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
| Not applicable |
Age-upper limit
| 18 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under 18 months of age requiring cardiopulmonary bypass
Key exclusion criteria
1. Patients who meet the study criteria for the second time or more during the study period.
2. Other patients whom the principal investigator or co-investigator deems unsuitable for inclusion in this study.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Department of Anesthesiology
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513111
kimsato1034@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Kyoto University Hospital Clinical Research Consultation Desk
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513111
Homepage URL
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
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
Kyoto University Hospital Clinical Research Consultation Desk
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
0757513111
ctsodan@kuhp.kyoto-u.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
| 2024 | Year | 11 | Month | 07 | 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
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064093
