UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between levels of central nervous system (CNS)-derived proteins and pediatric delirium after cardiac surgery
Acronym	The relationship between levels of central nervous system (CNS)-derived proteins and pediatric delirium after cardiac surgery
Scientific Title	The relationship between levels of central nervous system (CNS)-derived proteins and pediatric delirium after cardiac surgery
Scientific Title:Acronym	The relationship between levels of central nervous system (CNS)-derived proteins and pediatric delirium after cardiac surgery
Region	Japan

Condition
Condition	Enrollment criteria included patients aged under 18 years, undergoing scheduled cardiovascular patients.
Classification by specialty	Pediatrics Intensive care medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is revealing the association between levels of central nervous system (CNS)-derived proteins and pediatric delirium after cardiac surgery
Basic objectives2	Others
Basic objectives -Others	relationship
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Delirium coma-free days.
Key secondary outcomes	Prevalence of delirium. Delirium days. correlation between each item of delirium scales and central nervous system (CNS)-derived proteins.

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 years-old >=
Gender	Male and Female
Key inclusion criteria	Enrollment criteria included patients aged under 18 years, undergoing scheduled cardiovascular between August 2019 to October 2019.
Key exclusion criteria	Patients were excluded if they diagnosed brain dysfunction.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Inoue
Organization	University of Tsukuba
Division name	Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code	305-8577
Address	1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
TEL	029-853-5633
Email	er-icu@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Yujiro Middle name Last name Matsuishi
Organization	University of Tsukuba
Division name	Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code	305-8577
Address	1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
TEL	029-853-5633
Homepage URL
Email	matsuishi.yujiro.xa@alumni.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	None
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	Institutional Review Board of the University of Tsukuba
Address	1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
Tel	0298533941
Email	t-credo.adm@un.tsukuba.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	2019 Year 08 Month 22 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	2019 Year 02 Month 15 Day
Date of IRB	2019 Year 06 Month 25 Day
Anticipated trial start date	2019 Year 08 Month 22 Day
Last follow-up date	2019 Year 10 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	2019 Year 08 Month 20 Day
Last modified on	2019 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042772