UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042858 |
|---|---|
| Receipt number | R000048910 |
| Scientific Title | The frequency of postoperative BNP measurement and intervention threshold of BNP concentration in pediatric cardiac intensive care unit: Multicenter study in Japan |
| Date of disclosure of the study information | 2020/12/26 |
| Last modified on | 2020/12/26 01:01:08 |
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Basic information
Public title
The frequency of postoperative BNP measurement and intervention threshold of BNP concentration in pediatric cardiac intensive care unit: Multicenter study in Japan
Acronym
Post operative BNP study for CHD children in Japan
Scientific Title
The frequency of postoperative BNP measurement and intervention threshold of BNP concentration in pediatric cardiac intensive care unit: Multicenter study in Japan
Scientific Title:Acronym
Post operative BNP study for CHD children in Japan
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate therapeutic intervention threshold of BNP concentration in pediatric cardiac intensive care unit
Basic objectives2
Others
Basic objectives -Others
how did the Japanese pediatric cardiac intensivists measure BNP in PCICU
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the threshold of BNP values for any therapeutic interventions
Key secondary outcomes
how did the Japanese pediatric cardiac intensivists measure BNP in PCICU
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We included all patients under 15 years of age who underwent pediatric cardiac surgery with or without cardiopulmonary bypass (CPB) during the period
Key exclusion criteria
We excluded those who could not later be analyzed due to missing data
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kanazawa |
Organization
Okayama University Hospital
Division name
Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku
TEL
0862357778
tyskanazawa@gmail.com
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kanazawa |
Organization
Okayama University Hospital
Division name
Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1, Shikata-cho, Kita-ku
TEL
0862357778
Homepage URL
tyskanazawa@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
Okayama University Hospital Institutional Review Board
Address
2-5-1 Shikatachou, Kitaku, Okayama, Okayama 700-8525, Japan
Tel
0862356503
mae6605@adm.okayama-u.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
| 2020 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.okadaimasui.com/jp/clinicalstudy/index.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.okadaimasui.com/jp/clinicalstudy/index.html
Number of participants that the trial has enrolled
108
Results
A total of 246 BNP measurements for 108 patients were included. 39 measurements were used as a criterion to decide to intervene children. The number of BNP measurements in each group is as follows: group A 113, group B 81, group C 45, group D 7. The intervention ratio in each group was 6.2% (group A), 8.6% (group B), 44.4% (group C), and 71.4% (group D). The intervention ratio of group C and D were significantly higher than group A: (Odds ratio (95%CI): 12.1(4.8-33.9), p<0.0001, 25.2(5.2-146.2), p<0.0001).
Results date posted
| 2020 | Year | 12 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of the patients was 5 (1,17.5: interquartile range, IQR) months and the median weight was 4.6 (3.2,8.4: IQR) kg. Of all patients, 58.2% were male.
Participant flow
After admission to the pediatric cardiac intensive care unit, all BNPs enrolled in the study and measured during admission were prospectively extracted.
Adverse events
none
Outcome measures
BNP measurement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 17 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 20 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 26 | Day |
Last modified on
| 2020 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048910
