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Trial record 2 of 31 for:    "Kawasaki syndrome"

Different Doses of IVIG for Kawasaki Disease

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ClinicalTrials.gov Identifier: NCT02439996
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
Shanghai Children's Medical Center
Shanghai Children's Hospital
Information provided by (Responsible Party):
Guoying huang, Children's Hospital of Fudan University

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 Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

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 Name: 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 Name: 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 Name: Asprin




Primary Outcome Measures :
  1. Duration of fever subsided to normal after initial IVIG finished [ Time Frame: 36 hours after IVIG finished ]
    Hours of fever subsided to normal after initial IVIG finished

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

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

  3. incidence of coronary artery lesions(CAL) after IVIG finished [ Time Frame: 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

  4. Total dose of immunoglobin used for every patient [ Time Frame: estimated about up to 10 days, start from admission,ended by discharge ]
    Total dose of immunoglobin used for every patient

  5. total medical cost for KD treatment during hospital stay [ Time Frame: 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

  6. total frequency (%) of severe adverse events [ Time Frame: 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



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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439996


Locations
China, Shanghai
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

Responsible Party: Guoying huang, Professor,President, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02439996     History of Changes
Other Study ID Numbers: KD(2015-2016)
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Guoying huang, Children's Hospital of Fudan University:
Kawasaki disease IVIG

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Methylprednisolone
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Immunologic Factors