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Different Doses of IVIG for Kawasaki Disease: a Multicentre, Prospective, Randomised Trial
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 .
Age
0 - 12 years
Sex
ALL
Healthy Volunteers
No
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Start Date
January 1, 2014
Primary Completion Date
March 1, 2016
Completion Date
September 1, 2016
Last Updated
May 11, 2018
404
ACTUAL participants
IVIG (1g/kg,once)
DRUG
IVIG (1g/kg,twice)
DRUG
IVIG (2g/kg.once)
DRUG
Lead Sponsor
Children's Hospital of Fudan University
Collaborators
NCT07291245
NCT05643651
Data Source & Attribution
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