Unique ID issued by UMIN | UMIN000039141 |
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Receipt number | R000044643 |
Scientific Title | High-dose versus low-dose intravenous immunoglobulin for treatment of children with Kawasaki disease weighing 25 kg or more |
Date of disclosure of the study information | 2020/01/13 |
Last modified on | 2020/01/13 23:35:47 |
High-dose versus low-dose intravenous immunoglobulin for treatment of children with Kawasaki disease weighing 25 kg or more
OLDERKD
High-dose versus low-dose intravenous immunoglobulin for treatment of children with Kawasaki disease weighing 25 kg or more
OLDERKD
Japan |
Patients who were diagnosed with Kawasaki Disease (KD) (ICD-10 codes M303) between September 2010 and September 2017.
Of these, we included patients who weighed 25 kg and more than 25kg and who received 1 g/kg and more than 1g/kg IVIG within 5 days of their initial hospital admission for KD.
We divided the remaining cases into two groups of patients treated initially with 2 g/kg or 1 g/kg IVIG within 3 days, respectively.
Medicine in general | Cardiology | Pediatrics |
Child |
Others
NO
The purpose of this study was to compare the outcomes in terms of the proportions of coronary artery abnormalities, Intravenous immunoglobulin (IVIG) resistance, length of stay, adverse effects of IVIG, and medical costs between children with KD weighing 25 kg and more than 25kg treated with either 1 g/kg or 2 g/kg IVIG, using information from a Japanese national inpatient database.
Efficacy
The primary outcome was CAA at the time of discharge in the two groups. CAA was defined as the use of warfarin, clopidogrel, or receipt of cardiac catheterization, in addition to a diagnosis of CAA in the database.
Secondary outcomes were the proportions of IVIG resistance, length of stay, medical costs, and IVIG-related side effects. IVIG resistance was defined as receiving IVIG at a total dose of 2.5 g/kg or more than 2.5 g/kg at intervals of more than 6 days. Additional treatments were defined as use of corticosteroids after day 5 at initial IVIG treatment, infliximab, plasma exchange, and cyclosporine. We also examined side effects attributed to IVIG treatments.
Interventional
Factorial
Non-randomized
Open -no one is blinded
Dose comparison
2
Treatment
Medicine |
children with KD weighing 25 kg and more treated with 1 g/kg IVIG
children with KD weighing 25 kg and more treated with 2 g/kg IVIG
Not applicable |
Not applicable |
Male and Female
We identified patients in the database who were diagnosed with KD (ICD-10 codes M303) between September 2010 and September 2017.Of these, we included patients who weighed 25 kg and more and who received 1 g/kg and more IVIG within 5 days of their initial hospital admission for KD.
Patients with atypical KD and who did not use IVIG within 5 days.
1300
1st name | Nobuaki |
Middle name | |
Last name | Michihata |
The University of Tokyo
Department of Health Services Research, Graduate School of Medicine
157-0033
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
+81-3-5841-1887
michihata-tky@umin.org
1st name | Nobuaki |
Middle name | |
Last name | Michihata |
The University of Tokyo
Department of Health Services Research, Graduate School of Medicine
157-0033
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
+81-3-5841-1887
michihata-tky@umin.org
The University of Tokyo
the Ministry of Health, Labour and Welfare, Japan and the Ministry of Education, Culture, Sports, Science and Technology, Japan
Japanese Governmental office
Office for Human Research Studies(OHRS)
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
NO
2020 | Year | 01 | Month | 13 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044643
Unpublished
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044643
1134
We identified 1134 patients with KD.
2020 | Year | 01 | Month | 13 | Day |
The participants who received 2 g/kg IVIG and 198 patients who received 1 g/kg IVIG as an initial treatment. Propensity score matching created 788:197 (4:1) pairs.
A total of 788:197 (4:1) propensity score-matched pairs were created between the 2 g/kg and 1 g/kg IVIG groups.
One patient in the IVIG 2 /kg group developed acute coronary syndrome and no patients were diagnosed with hyperviscosity syndrome.
There were no significant differences between the 2 g/kg and 1 g/kg IVIG groups in terms of the proportions of CAA (5.3% vs. 4.1%, respectively; p=0.587), IVIG resistance (20.3% vs. 14.2%, respectively; p=0.054), and length of stay (12.6 days vs. 13.6 days, respectively; p=0.206). Medical costs were significantly higher in the 2 g/kg compared with the1 g/kg group (12,754 USD vs. 8920 USD, respectively; p<0.001). The numbers of side effects of IVIG were too small to be compared.
Completed
2010 | Year | 07 | Month | 01 | Day |
2018 | Year | 06 | Month | 13 | Day |
2010 | Year | 09 | Month | 01 | Day |
2017 | Year | 09 | Month | 30 | Day |
2020 | Year | 01 | Month | 13 | Day |
2020 | Year | 01 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044643
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