UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between myocardial temperature monitoring and postoperative cardiac dysfunction in pediatric cardiac surgery
Acronym	relationship between myocardial temperature monitoring and pediatric cardiac surgery
Scientific Title	Relationship between myocardial temperature monitoring and postoperative cardiac dysfunction in pediatric cardiac surgery
Scientific Title:Acronym	relationship between myocardial temperature monitoring and pediatric cardiac surgery
Region	Japan

Condition
Condition	heart disease
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will 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	Postoperative cardiac dysfunction marker, cardiac function evaluation, 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	Children undergoing cardiac surgery using all heart-lung machines during the period
Key exclusion criteria	Patients with severe renal dysfunction before surgery or in extremely poor condition such as resuscitation
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	Cardiovascular Surgery
Zip code	1138431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL	08034162802
Email	knakani@juntendo.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Nakanishi
Organization	Juntendo University
Division name	Cardiovascular Surgery
Zip code	1138431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL	08034162802
Homepage URL
Email	knakani@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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
Tel	08034162802
Email	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	2024 Year 03 Month 31 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	Preinitiation
Date of protocol fixation	2021 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2024 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	2021 Year 07 Month 13 Day
Last modified on	2021 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051222