UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046780
Receipt number R000053293
Scientific Title Changes in cerebral blood flow indices by transcranial doppler and cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery
Date of disclosure of the study information 2022/02/01
Last modified on 2022/08/02 09:07:16

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Basic information

Public title

Evaluation of changes in cerebral circulation in the palliative surgery for congenital heart disease

Acronym

Changes in cerebral circulation in the palliative surgery for congenital heart disease

Scientific Title

Changes in cerebral blood flow indices by transcranial doppler and cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery

Scientific Title:Acronym

Changes in cerebral blood flow indices and oxygenation in pediatric palliative 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 palliative cardiac surgery

Basic objectives2

Others

Basic objectives -Others

search 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 palliative cardiac surgery

Key secondary outcomes

changes in cerebral oxygenation by near infrared spectroscopy in pediatric palliative cardiac surgery


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

6 years-old >

Gender

Male and Female

Key inclusion criteria

The patients that underwent pediatric palliative cardiac surgery 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

43


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 or person

Institute

Hokkaido university hospital

Institute

Department

Personal name



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 02 Month 01 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

43

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

2022 Year 01 Month 17 Day

Date of IRB

2022 Year 02 Month 10 Day

Anticipated trial start date

2022 Year 02 Month 10 Day

Last follow-up date

2022 Year 06 Month 30 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:June 30, 2022
Subjects:The children who underwent pediatric palliative cardiac surgery 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 01 Month 30 Day

Last modified on

2022 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053293