Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Duration of fever subsided to normal after initial IVIG finished
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •The patients with the application of hormone or other immunosuppressive agents;
- •The patients didn't want to signed informed consent.
研究组 & 干预措施
IVIG(1g/kg,once)
The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once.
干预措施: IVIG (1g/kg,once) (Drug)
IVIG(1g/kg,twice)
The KD children will be randomly assigned to three groups. The patients in group B will receive IVIG 1g/kg for 2 days continuousl.
干预措施: IVIG (1g/kg,twice) (Drug)
IVIG(2g/kg.once)
The KD children will be randomly assigned to three groups. The patients in group A will receive IVIG 2g/kg once.
干预措施: IVIG (2g/kg.once) (Drug)
结局指标
主要结局
Duration of fever subsided to normal after initial IVIG finished
时间窗: 36 hours after IVIG finished
Hours of fever subsided to normal after initial IVIG finished
incidence of coronary artery lesions(CAL) after IVIG finished
时间窗: start from IVIG finished, ended by the end of 2 weeks
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
次要结局
- incidence of coronary artery lesions(CAL) after IVIG finished(start from IVIG finished, ended by the end of 6 month)
- total medical cost for KD treatment during hospital stay(estimated about up to 10 days, start from admission,ended by discharge)
- Total dose of immunoglobin used for every patient(estimated about up to 10 days, start from admission,ended by discharge)
- total frequency (%) of severe adverse events(estimated about up to 10 days, start from admission,ended by discharge)
研究者
Guoying huang
Professor,President
Children's Hospital of Fudan University