Different Doses of IVIG for Kawasaki Disease

Brief Title

Different Doses of IVIG for Kawasaki Disease

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 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 .
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Duration of fever subsided to normal after initial IVIG finished

Secondary Outcome

 incidence of coronary artery lesions(CAL) after IVIG finished

Condition

Kawasaki Disease

Intervention

IVIG (1g/kg,once)

Study Arms / Comparison Groups

 IVIG(1g/kg,once)

Description:  The KD children will be randomly assigned to three groups. The patients in group C will receive IVIG 1g/kg once.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

404

Start Date

January 2014

Completion Date

September 2016

Primary Completion Date

March 2016

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.
      

Gender

All

Ages

1 Month - 12 Years

Accepts Healthy Volunteers

No

Contacts

Guoying Huang, PHD, , 

Location Countries

China

Location Countries

China

NCT ID

NCT02439996

Organization ID

KD(2015-2016)

Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Fudan University

Collaborators

 Shanghai Children's Medical Center

Study Sponsor

Guoying Huang, PHD, Study Chair, Children Hospital of Fudan University

Verification Date

May 2018