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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031183
Receipt No. R000035599
Scientific Title Utility of noninvasive regional saturation monitoring using with INVOS500 to predict prognosis in pediatric patients with congenital heart disease
Date of disclosure of the study information 2018/02/07
Last modified on 2018/02/07

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Basic information
Public title Utility of noninvasive regional saturation monitoring using with INVOS500 to predict prognosis in pediatric patients with congenital heart disease
Acronym Noninvasive regional saturation monitoring and congenital heart surgery
Scientific Title Utility of noninvasive regional saturation monitoring using with INVOS500 to predict prognosis in pediatric patients with congenital heart disease
Scientific Title:Acronym Noninvasive regional saturation monitoring and congenital heart surgery
Region
Japan

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

Objectives
Narrative objectives1 To investigate the utility of noninvasive regional saturation monitoring in patients with congenital heart disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Poor outcomes including 30-day mortality, duration of ICU stay, duration of respiratory ventilation, administration of renal replacement therapy and ECMO
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
3 years-old >=
Gender Male and Female
Key inclusion criteria pediatric patients with congenital heart disease and body weight under 10 kg
Key exclusion criteria body weight over 10 kg
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Saito
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address zaifu-cho 53, Hirosaki, Aomori, Japan
TEL 0172-39-5113
Email masuika@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Saito
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address Zaifu-cho 53, Hirosaki, Aomori, Japan
TEL 0172-39-5113
Homepage URL
Email masuika@hirosaki-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Hirosaki University Graduate School of Medicine
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
Address
Tel
Email

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
2018 Year 02 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
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we measure cerebral and renal regional saturation preoperatively. we compared with regional saturation and other data including preoperative BNP, cardiac function, RACHS score and others.

Management information
Registered date
2018 Year 02 Month 07 Day
Last modified on
2018 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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