Different Doses of IVIG for Kawasaki Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial

Conditions
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Kawasaki Disease

Intervention / Treatment
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* Drug: IVIG (1g/kg,once)
* Drug: IVIG (1g/kg,twice)
* Drug: IVIG (2g/kg.once)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002. the patients aged from 1 months to 12 years old. All included patients required to sign an informed consent form. the patients didn't receive treatment before. Exclusion Criteria: The patients with the application of hormone or other immunosuppressive agents; The patients didn't want to signed informed consent.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVIG(1g/kg,once)<br>The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once. | Drug: IVIG (1g/kg,once)<br>* 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.<br>* Other names: Asprin;|
| Experimental: IVIG(1g/kg,twice)<br>The KD children will be randomly assigned to three groups. The patients in group B will receive IVIG 1g/kg for 2 days continuousl. | Drug: IVIG (1g/kg,twice)<br>* 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.<br>* Other names: Asprin;|
| Active Comparator: IVIG(2g/kg.once)<br>The KD children will be randomly assigned to three groups. The patients in group A will receive IVIG 2g/kg once. | Drug: IVIG (2g/kg.once)<br>* 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.<br>* Other names: Asprin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of fever subsided to normal after initial IVIG finished | Hours of fever subsided to normal after initial IVIG finished | 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 | start from IVIG finished, ended by the end of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of coronary artery lesions(CAL) after IVIG finished | incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography | 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 | 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 | 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 | 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 | 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 | estimated about up to 10 days, start from admission,ended by discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kawasaki disease IVIG