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Completed

NCT Number: NCT02439996

Different Doses of IVIG for Kawasaki Disease

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.

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

1 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVIG (1g/kg,once)

Drug

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

IVIG (1g/kg,twice)

Drug

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

IVIG (2g/kg.once)

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Shanghai Children's Hospital
  • Shanghai Children's Medical Center

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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