Clinical trial NCT02439996: Different Doses of IVIG for Kawasaki Disease
Official title: Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kawasaki Disease
Keywords: Kawasaki disease IVIG
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Medical Center
name: Shanghai Children's Hospital
First posted: 2015-05-12
Enrollment: 404
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of fever subsided to normal after initial IVIG finished
timeFrame: 36 hours after IVIG finished
measure: incidence of coronary artery lesions(CAL) after IVIG finished
timeFrame: start from IVIG finished, ended by the end of 2 weeks
Secondary outcomes:
measure: incidence of coronary artery lesions(CAL) after IVIG finished
timeFrame: start from IVIG finished, ended by the end of 1 month
measure: incidence of coronary artery lesions(CAL) after IVIG finished
timeFrame: start from IVIG finished, ended by the end of 3 month
measure: incidence of coronary artery lesions(CAL) after IVIG finished
timeFrame: start from IVIG finished, ended by the end of 6 month
measure: Total dose of immunoglobin used for every patient
timeFrame: estimated about up to 10 days, start from admission,ended by discharge
measure: total medical cost for KD treatment during hospital stay
timeFrame: estimated about up to 10 days, start from admission,ended by discharge
measure: total frequency (%) of severe adverse events
timeFrame: estimated about up to 10 days, start from admission,ended by discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children Hospital of Fudan University
name: Guoying Huang, PHD
role: STUDY_CHAIR
References:
citation: 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.