UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031183 |
|---|---|
| Receipt number | 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 11:36:03 |
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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
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
masuika@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035599
