The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.
Kawasaki disease is an acute febrile illness recognized most often in young children. Coronary abnormality is the most serious complication preventable with intravenous immunoglobulin (IVIG) administration. Various treatment regimens of IVIG have been reported.The optimal administrative doses of IVIG deserves more observations.We will conduct a multicenter, randomized, prospective trial to determine the effect of different doses of IVIG (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease. The KD children will be randomly assigned to three groups and were given different IVIG regimen (1g/kg once, 1g/kg twice, 2g/kg once)as initial treatment. Patient age, gender, white blood cell count, hemoglobin, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), red blood cell specific volume (HCT) , serum albumin, the fever days,and the cost of hospital stay will be analyzed among the three groups. The primary outcome is the duration of fever subsided and the incidence of coronary artery lesions .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
404
Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Duration of fever subsided to normal after initial IVIG finished
Hours of fever subsided to normal after initial IVIG finished
Time frame: 36 hours after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
Time frame: start from IVIG finished, ended by the end of 2 weeks
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
Time frame: start from IVIG finished, ended by the end of 1 month
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
Time frame: start from IVIG finished, ended by the end of 3 month
incidence of coronary artery lesions(CAL) after IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography and coronary atery angiogram
Time frame: start from IVIG finished, ended by the end of 6 month
Total dose of immunoglobin used for every patient
Total dose of immunoglobin used for every patient
Time frame: estimated about up to 10 days, start from admission,ended by discharge
total medical cost for KD treatment during hospital stay
record the hospital duration of every patient and the medical expenses for KD
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Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.
Time frame: estimated about up to 10 days, start from admission,ended by discharge
total frequency (%) of severe adverse events
Severe adverse events included death, infection or exacerbation, heart failure, allergic reaction, etc
Time frame: estimated about up to 10 days, start from admission,ended by discharge