UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of changes in cerebral circulation in pediatric cardiac surgery with cardiopulmonary bypass
Acronym	Changes in cerebral circulation in pediatric cardiac surgery
Scientific Title	Evaluation of changes in cerebral circulation in pediatric cardiac surgery with cardiopulmonary bypass
Scientific Title:Acronym	Changes in cerebral circulation in pediatric cardiac surgery
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the changes in cerebral blood flow indices by transcranial doppler and cerebral oxygenation by near infrared spectroscopy in pediatric cardiac surgery with cardiopulmonary bypass
Basic objectives2	Others
Basic objectives -Others	serach of physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in cerebral blood flow indices by transcranial doppler in pediatric cardiac surgery with cardiopulmonary bypass
Key secondary outcomes	changes in cerebral oxygenation by near infrared spectroscopy in pediatric cardiac surgery with cardiopulmonary bypass

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
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Eligibility
Age-lower limit	1 days-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients that underwent pediatric cardiac surgery with cardiopulmonary bypass from August 10, 2017 to December 31, 2020 and agreed to attend the clinical observational prospective study "evaluation of cerebral circulation in pediatric cardiac surgery using transcranial doppler and near infrared spetroscopy "(No 016-0505) by written informed consent.
Key exclusion criteria	1 the patients with intracranial disorders 2 the patients who refuse the attendance of the study after optout
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Morimoto
Organization	Hokkaido university hospital
Division name	Department of Anesthesiology
Zip code	0608648
Address	N14 W5, Kita-ku, Sapporo
TEL	0117161161
Email	morim2@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Morimoto
Organization	Hokkaido university hospital
Division name	Department of Anesthesiology
Zip code	0608648
Address	N14 W5, Kita-ku, Sapporo
TEL	0117161161
Homepage URL
Email	morim2@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido university hospital
Institute
Department

Funding Source
Organization	self funding
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	Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address	N14 W5, Kita-ku, Sapporo
Tel	0117067636
Email	crjimu@huhp.hokudai.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	北海道大学病院

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 20 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Design;Retrospective observational study Last follow-up data:March 31, 2023 Subjects:The children who underwent pediatric cardiac surgery with cardiopulmonary bypass from August 10, 2017 to December 31, 2020 in Hokkaido university hospital Observational items: cerebral blood flow indices, cerebral oxygenation, background, image examination, blood test, vital signs, etc.

Management information
Registered date	2022 Year 05 Month 19 Day
Last modified on	2022 Year 05 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054499

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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