Corticosteroids plus standard of care treatment versus standard of care treatment alone to prevent heart complications in Kawasaki disease
- Conditions
- Coronary artery aneurysms in Kawasaki diseaseCirculatory System
- Registration Number
- ISRCTN71987471
- Lead Sponsor
- niversity College London
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36703139/ (added 27/01/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 262
1. Aged 30 days (post-natal age) to 15 years inclusive, and below the country-specific age of consent
2. KD defined in at least one of the three following ways:
2.1. As per American Heart Association (AHA) criteria: namely fever for at least five days in addition to 4 of the following 5 criteria:
2.2.1. Bilateral non purulent conjunctivitis
2.2.2. Cervical lymphadenopathy
2.2.3. Polymorphous skin rash
2.2.4. Changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)
2.2.5. Extremity changes (erythema, oedema of palms and soles in initial phase, and at convalescent stage skin peeling)
2.2. OR less than 5 days of fever but all five clinical criteria above
2.3. OR incomplete KD cases, as per a modified*AHA definition, namely:
2.3.1. Children/adolescents (> 1 year old) with fever greater than or equal to 5 days AND at least 2 other compatible clinical criteria as listed above; OR infants < = 1 year old with fever > = 7 days without other explanation;
AND for both age groups:
2.3.2. CRP > = 30 mg/L or erythrocyte sedimentation rate (ESR) > = 40 mm/h (or both)
AND for both age groups
2.3.3. EITHER the presence of any 3 or more of: anaemia for age (haemoglobin < lower limit of normal reference range for local laboratory) platelet count > = 450 x10?/L or < 140 x10?/L; albumin < 30 g/L; elevated ALT (> upper limit of normal reference range for local laboratory); white cell count > = 15 x10?/L; urine > = 10 white blood cells per high power field
2.3.4. OR abnormal echocardiogram compatible with KD but without established CAA, with > = 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2< Z< 2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).
3. Written informed consent from appropriate legal representative(s), and assent from patients who have not reached the age of consent in the participating country, but are judged to have capacity for this (depending on both age and acuity of illness)
*This definition of incomplete KD is modified from the AHA definition by firstly, the exclusion of aneurysmal coronary artery changes as the sole echo finding, since this is an exclusion criterion for KD-CAAP, and secondly the inclusion of low platelet count as well as high platelet count, as highlighted in recent European consensus SHARE guideline.
Note that patients with KD can still be included in KD-CAAP if they have started IVIG treatment, as long as they are randomised no more than 24 hours after the IVIG infusion is initiated (see exclusion criteria below).
Test results must be from tests done on the calendar day of randomisation or the day before.
Disease-related exclusions:
1. This diagnosis is a second or further episode of KD
2. Already established CAA at screening
3. Severe Congestive Heart Failure or cardiogenic shock defined as the presence of hypotension and shock requiring the initiation of volume expanders
4. Known congenital coronary artery abnormality that would impair assessment of the primary endpoint
5. Suspected macrophage activation syndrome
Exclusions related to medications:
6. Started IVIG more than 24 hours prior to randomisation
7. Known hypersensitivity to prednisolone or methylprednisolone
8. Current oral, intravenous or intramuscular corticosteroid treatment for more than 3 days in previous 7 days prior to randomisation
9. History of previous severe reaction to any human immune globulin preparation
Exclusions related to general health or other issues:
10. Active varicella zoster virus infection; or known exposure to a case of varicella within the previous 21 days prior to randomisation if known to be non-immune
11. Co-enrolment in another study/trial of an investigative medicinal product
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method