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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
| Shanghai Children's Hospital | OTHER |
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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG(1g/kg,once) | Experimental | The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once. |
|
| IVIG(1g/kg,twice) | Experimental | The KD children will be randomly assigned to three groups. The patients in group B will receive IVIG 1g/kg for 2 days continuousl. |
|
| IVIG(2g/kg.once) | Active Comparator | The KD children will be randomly assigned to three groups. The patients in group A will receive IVIG 2g/kg once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG (1g/kg,once) | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoying Huang, PHD | Children Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33600060 | Derived | He L, Liu F, Yan W, Huang M, Huang M, Xie L, Guo Y, Xu X, Chu C, Wu L, Liang X, Sun S, Wang F, Zhao L, Zhao Q, Ma X, Xie L, Huang G. Randomized trial of different initial intravenous immunoglobulin regimens in Kawasaki disease. Pediatr Int. 2021 Jul;63(7):757-763. doi: 10.1111/ped.14656. Epub 2021 Jun 16. |
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| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| C010395 | acetylsalicylic acid lysinate |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| IVIG (1g/kg,twice) | Drug | 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. |
|
|
| IVIG (2g/kg.once) | Drug | 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. |
|
|
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 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |