UMIN-CTR Clinical Trial

Basic information
Public title	Sodium-containing versus sodium-trace preparations of IVIG for children with Kawasaki disease in the acute phase
Acronym	Sodium-containing versus sodium-trace preparations of IVIG for children with Kawasaki disease in the acute phase
Scientific Title	Sodium-containing versus sodium-trace preparations of IVIG for children with Kawasaki disease in the acute phase
Scientific Title:Acronym	Sodium-containing versus sodium-trace preparations of IVIG for children with Kawasaki disease in the acute phase
Region	Japan

Condition
Condition	Kawasaki Disease
Classification by specialty	Cardiology Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the present study was to compare the outcomes of KD children treated with high-Na and low-Na IVIG preparations using a national inpatient database in Japan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coronary artery abnormalities
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	High Na IVIG
Interventions/Control_2	Low Na IVIG
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	1 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	We used the Diagnostic Procedure Combination database to identify KD patients treated with IVIG between 2010 and 2017 and further identified those receiving high-Na and low-Na IVIG preparations as their initial treatment. The study outcomes included proportion of CAAs, proportion of IVIG resistance, length of stay, and medical cost. Propensity score-matched analyses were conducted to compare the outcomes between the two groups. Instrumental variable analyses were performed to confirm the results.
Key exclusion criteria	exclude patients with a suspected diagnosis of KD, inadequate treatment, and age over 6 years.
Target sample size	42345

Research contact person
Name of lead principal investigator	1st name Nobuaki Middle name Last name Michihata
Organization	The University of Tokyo
Division name	Department of Health Services Research, Graduate School of Medicine
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku
TEL	0358411887
Email	gha10771@gmail.com

Public contact
Name of contact person	1st name Nobuaki Middle name Last name Michihata
Organization	The University of Tokyo
Division name	Department of Health Services Research, Graduate School of Medicine
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku
TEL	0358411887
Homepage URL
Email	gha10771@gmail.com

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	The University of Tokyo
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	The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku
Tel	+81358411887
Email	gha10771@gmail.com

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 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	42345
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	Completed
Date of protocol fixation	2020 Year 12 Month 16 Day
Date of IRB	2017 Year 12 Month 25 Day
Anticipated trial start date	2020 Year 12 Month 16 Day
Last follow-up date	2020 Year 12 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 16 Day
Last modified on	2020 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048812