Different Doses of IVIG for Kawasaki Disease
- Conditions
- Kawasaki Disease
- Interventions
- Drug: IVIG (1g/kg,once)Drug: IVIG (1g/kg,twice)Drug: IVIG (2g/kg.once)
- Registration Number
- NCT02439996
- Lead Sponsor
- Children's Hospital of Fudan University
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
- 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.
- The patients with the application of hormone or other immunosuppressive agents;
- The patients didn't want to signed informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IVIG(1g/kg,once) 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. IVIG(1g/kg,twice) 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. IVIG(2g/kg.once) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
incidence of coronary artery lesions(CAL) after IVIG finished start from IVIG finished, ended by the end of 6 month incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography and coronary atery angiogram
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 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
Trial Locations
- Locations (1)
Children Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China