Clinical Trial: Different Doses of IVIG for Kawasaki Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial

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 Summary: 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 receive three doses of IVIG (1g/kg once, 1g/kg twice, 2g/kg once). 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. All the patients will be detected the 6 genes polymorphisms including ITPKC、CASP3、HLA、BLK、FCGR2A and CD40. The final outcome is the rates of IVIG unresponsiveness and the incidence of coronary artery lesions .
Sponsor: Children's Hospital of Fudan University

Current Primary Outcome: The fever days of KD patients [ Time Frame: 2.25 years ]

The fever days of KD patients will be analyzed among the three groups.


Original Primary Outcome: The fever days of KD patients [ Time Frame: 3 years ]

The fever days of KD patients will be analyzed among the three groups.


Current Secondary Outcome: incidence of coronary artery lesions(CAL) [ Time Frame: 2.25 years ]

Echocardiography is performed in the acute phase ,early and late recovery of Kawasaki disease.


Original Secondary Outcome: incidence of coronary artery lesions(CAL) [ Time Frame: 3 years ]

Echocardiography is performed in the acute phase ,early and late recovery of Kawasaki disease.


Information By: Children's Hospital of Fudan University

Dates:
Date Received: May 7, 2015
Date Started: January 2014
Date Completion:
Last Updated: September 8, 2016
Last Verified: January 2014