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The combination treatment of low-dose methylprednisolone and intravenous immunogloblin for patients with Kawasaki disease at high-risk of IVIG resistance: a multi-center randomized controlled clinical study.

The combination treatment of low-dose methylprednisolone and intravenous immunogloblin for patients with Kawasaki disease at high-risk of IVIG resistance: a multi-center randomized controlled clinical study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093344
Enrollment
Unknown
Registered
2024-12-03
Start date
2024-12-03
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease

Interventions

Intervention group:The combination treatment of low-dose methylprednisolone (2mg/kg/day q12h) and intravenous immunoglobulin (2g/kg)
Control group:The basic treatment of intravenous immunoglobulin (2g/kg)

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 10 Years

Inclusion criteria

Inclusion criteria: (1) The legal guardian shall provide a written informed consent form according to the requirements of the region or the Institutional Review Board (IRB); (2) Patients who meet the diagnostic criteria for Kawasaki disease of the American Heart Association (AHA) in 2017, and are under 10 years of age; (3) Patients did not receive any Kawasaki disease-related treatment within 10 days after the onset of the disease; (4) Patients with Kawasaki disease meet the criteria for high-risk IVIG resistance as follows, NLR>11.7, CRP>170mg/L, Na25µmol/L, ALT>250 U/L, AST >177 U/L.

Exclusion criteria

Exclusion criteria: (1) The disease duration of patients with Kawasaki disease was more than 10 days; (2) Patients received IVIG or steroid treatment at other hospitals; (3) Patients were diagnosed with cardiac shock or macrophage activation syndrome (MAS), which requires the early application of the high-dose steroid treatment, etc; (4) Patients had the contraindications of steroids and/or IVIG, etc.

Design outcomes

Primary

MeasureTime frame
The fever at 48 hours after IVIG treatment;

Secondary

MeasureTime frame
CALs;The changes of inflammatory indexes;

Countries

China

Contacts

Public ContactLiu Xiaoliang

West China Second University Hospital, Sichuan University

sdigjoy@qq.com+86 180 3078 1175

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026