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Research on individualized treatment for intravenous immunoglobulin resistant children with Kawasaki disease

Research on individualized treatment for intravenous immunoglobulin resistant children with Kawasaki disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16007862
Enrollment
Unknown
Registered
2016-01-30
Start date
2016-01-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Kawasaki disease

Interventions

IVIG+ASP group:IVIG(2g/kg.d)+ASP(30-50mg/kg.d)
IVIG+ASP+methylprednisolone group:IVIG+ASP+methylprednisolone

Sponsors

Children’s Hospital affiliated to Capital Institute of Pediatrics
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: The KD diagnosis was based on 5th edition diagnostic criteria revised by the Japanese KD Research Committee: (1) fever lasting longer than 5 d (including cases who were responsive to treatment with a fever lasting less than 5 d); (2) binocular conjunctival congestion (no exudation); (3) changes in the lip and oral cavity, flushed lips and rhagades, strawberry-like tongue, oral and pharyngeal mucosal diffuse hyperemia; (4) polymorphous rash; (5) changes in the tail end of limbs, palmoplantar redness, hard swelling in the finger (toe) tip; (6) acute non-suppurative cervical lymphadenopathy that was often unilateral, diameter greater than 1.5 cm. KD was diagnosed if patients presented with five or more of the criteria. KD was also diagnosed in patients who met four of the criteria and had a coronary artery aneurysms or coronary artery ectasia observable by two-dimensional echocardiogram or coronary arteriography. Non-responders were defined as: (1) continued high fever (>38.0 degree C) 36 h after treating with IVIG+ASP in 5-10 d; or (2) recurrent fever within 2-7 d after IVIG infusion, accompanied by other clinical manifestations of KD.

Exclusion criteria

Exclusion criteria: (1) Relapsing KD; (2) Rehospitalization due to resistant to the initial treatment; (3) Before admission received non-standard therapy; (4) Concurrent with other vascular inflammatory diseases; (5) Incomplete clinical data; (6) Do not meet the IVIG no response definition.

Design outcomes

Primary

MeasureTime frame
white blood cell;hemoglobin;platelet;the percent of neutrophile granulocyte;alanine transaminase;aspartate aminotransferase;gamma-glutamyl transpeptidase;sodium;erythrocyte sedimentation rate;C-reactive protein;albumin;Gene;

Countries

China

Contacts

Public ContactXiaohui Li
lxhmaggie@126.com+86 13641091775

Outcome results

None listed

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