UMIN-CTR Clinical Trial

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
Email	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
Email	tyskanazawa@gmail.com

Sponsor
Institute	Okayama University Hospital
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	Okayama University Hospital Institutional Review Board
Address	2-5-1 Shikatachou, Kitaku, Okayama, Okayama 700-8525, Japan
Tel	0862356503
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048910