Different Doses of IVIG for Kawasaki Disease

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT02439996

Collaborator

Shanghai Children's Medical Center (Other), Shanghai Children's Hospital (Other)

404

Enrollment

Location

Arms

Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kawasaki Disease	Drug: IVIG (1g/kg,once) Drug: IVIG (1g/kg,twice) Drug: IVIG (2g/kg.once)	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

404 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: IVIG (1g/kg,once) Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once. Other Names: Asprin
Experimental: 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.	Drug: IVIG (1g/kg,twice) Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once. Other Names: Asprin
Active Comparator: 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.	Drug: IVIG (2g/kg.once) Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once. Other Names: Asprin

Arm

Intervention/Treatment

Experimental: 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.

Drug: IVIG (1g/kg,once)

Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.

Other Names:

Asprin

Experimental: 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.

Drug: IVIG (1g/kg,twice)

Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.

Other Names:

Asprin

Active Comparator: 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.

Drug: IVIG (2g/kg.once)

Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h. Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once.

Other Names:

Asprin

Outcome Measures

Primary Outcome Measures

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

incidence of coronary artery lesions(CAL) after IVIG finished [start from IVIG finished, ended by the end of 1 month]
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
incidence of coronary artery lesions(CAL) after IVIG finished [start from IVIG finished, ended by the end of 3 month]
incidence of coronary artery lesions(CAL) after IVIG finished diagnosed by echocardiography
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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children Hospital of Fudan University	Shanghai	Shanghai	China	201102

Sponsors and Collaborators

Children's Hospital of Fudan University
Shanghai Children's Medical Center
Shanghai Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guoying huang, Professor,President, Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT02439996

Other Study ID Numbers:

KD(2015-2016)

First Posted:

May 12, 2015

Last Update Posted:

May 11, 2018

Last Verified:

May 1, 2018

Keywords provided by Guoying huang, Professor,President, Children's Hospital of Fudan University

Kawasaki disease IVIG

Additional relevant MeSH terms:

Mucocutaneous Lymph Node Syndrome

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Study Results

No Results Posted as of May 11, 2018