UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042763 |
|---|---|
| Receipt number | R000048812 |
| Scientific Title | Sodium-containing versus sodium-trace preparations of IVIG for children with Kawasaki disease in the acute phase |
| Date of disclosure of the study information | 2020/12/16 |
| Last modified on | 2020/12/16 00:50:14 |
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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
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
gha10771@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048812
