Kawasaki disease
Conditions
Interventions
Group A:Intravenous immunogloblin (2g/kg). Oral moderate-dose aspirin 30-50mg/kg per day in 3 divided doses in the initial treatment until the patient is afebrile for at least 48 hours, followed by as
Group B:Intravenous immunogloblin (2g/kg). Oral moderate-dose aspirin 3-5mg/kg per day for at least 8 weeks after the IVIG infusion.
Sponsors
Guangzhou Women and Children's Medical Center, China
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with Kawasaki disease according to the diagnostic criteria from the 2017 American Heart Association scientific statement, including complete Kawasaki disease (also known as typical or classic Kawasaki disease) and incomplete Kawasaki disease (also sometimes known as atypical Kawasaki disease); 2.Not yet treated with intravenous immunogloblin or aspirin; 3.Under the age of 18 years old.
Exclusion criteria
Exclusion criteria: 1. A previous history of Kawasaki disease diagnosis; 2. Afebrile prior to enrollment (axillary temperature lower than 37.5? for at least 24 hours); 3. Known congenital coronary artery abnormality or previous coronary artery surgery; 4. Contraindications for aspirin (e.g., known hypersensitivity to aspirin, glucose-6-phosphate dehydrogenase deficiency, active varicella zoster virus or influenza infection, or recent herpes zoster vaccination, etc.); 5. Intravenous immunogloblin treatment in the 180 days prior to randomization or oral aspirin in the previous 7 days; 6. The presence of concomitant severe medical disorders (e.g., immunodeficiency, chromosomal anomalies, etc.); 7. The presence of or the tendency for Kawasaki disease shock syndrome or other severe fulminant inflammation, requiring for more additional anti-inflammatory treatments (e.g., corticosteroids, infliximab, etc) in initial therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of coronary artery abnormalities at 8 weeks from IVIG infusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion receiving rescue treatment;Duration of fever from initiation of initial IVIG administration to normothermia condition;The Z-scores of internal coronary artery diameter;Changes in laboratory parameters of inflammation and hepatorenal function throughout the study period;Frequency of clinical adverse events judged related to IVIG or aspirin administration; | — |
Countries
China
Contacts
Public ContactWang Zhouping
Guangzhou Women and Children's Medical Center, China
Outcome results
None listed