Kawasaki Disease
Conditions
Keywords
Kawasaki disease IVIG
Brief summary
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
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 .
Interventions
DRUGIVIG (1g/kg,once)
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.
DRUGIVIG (1g/kg,twice)
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.
DRUGIVIG (2g/kg.once)
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.
Sponsors
Shanghai Children's Medical Center
Shanghai Children's Hospital
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of fever subsided to normal after initial IVIG finished | 36 hours after IVIG finished | Hours of fever subsided to normal after initial IVIG finished |
| incidence of coronary artery lesions(CAL) after IVIG finished | start from IVIG finished, ended by the end of 2 weeks | incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of coronary artery lesions(CAL) after IVIG finished | start from IVIG finished, ended by the end of 1 month | incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography |
| Total dose of immunoglobin used for every patient | estimated about up to 10 days, start from admission,ended by discharge | Total dose of immunoglobin used for every patient |
| total medical cost for KD treatment during hospital stay | estimated about up to 10 days, start from admission,ended by discharge | record the hospital duration of every patient and the medical expenses for KD |
| total frequency (%) of severe adverse events | estimated about up to 10 days, start from admission,ended by discharge | Severe adverse events included death, infection or exacerbation, heart failure, allergic reaction, etc |
Countries
China
Outcome results
None listed