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Evaluation of the clinical effectiveness of hormone therapy alone versus IVIG combined with hormone therapy for second dose IVIG unresponsive Kawasaki disease: a multicenter randomized controlled t

Evaluation of the clinical effectiveness of hormone therapy alone versus IVIG combined with hormone therapy for second dose IVIG unresponsive Kawasaki disease: a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079564
Enrollment
Unknown
Registered
2024-01-05
Start date
2024-01-05
Completion date
Unknown
Last updated
2025-01-13

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:IVIG+solu-medrol 2mg/kg
control group:solu-medrol 2mg/kg

Sponsors

Shenzhen Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria of Kawasaki disease in China in 2022 and do not respond to treatment with two doses of IVIG (2) Initial IVIG treatment within 10 days of the onset of the disease (3) Hospitalized in the cardiology Department of Shenzhen Children's Hospital with informed consent of the child's family members.

Exclusion criteria

Exclusion criteria: 1) The first IVIG treatment was given 10 days after the onset of the disease. (2) Patients who have received IVIG or hormone therapy in other hospitals. (3) Patients with combined shock or MAS requiring early application of hormone therapy. (4) There are contraindications for the use of experimental drugs such as hormones and IVIG. (5) If the fever ended after the second dose of IVIG, the case was not considered as a study object, but the relevant parameters of the case were recorded.

Design outcomes

Primary

MeasureTime frame
Coronary artery diameter;

Secondary

MeasureTime frame
Heating time;Hospital stay;Hospitalization expenses;

Countries

China

Contacts

Public ContactBoning Li

Shenzhen Children's Hospital

liboning10125@163.com+86 18938690172

Outcome results

None listed

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