Protocol summary
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Study aim
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The effect of initial treatment with intravenous corticosteroid pulse on the prevention of coronary artery abnormality in children with kawasaki disease,possibility to replace steroid pulse as a cheap and inexpensive treatment rather than expensive medicine.
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Design
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Clinical trial with control group, with parallel groups, one blind, randomized
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Settings and conduct
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After explaining to their parents and obtaining informed consent for treatment with IVIG or methylprednisolone pulse, patients are randomly assigned to two group: control group treatment with IVIG2g / kg, aspirin and intervention group treatment with intravenous puls of methyl prednisolone 30 mg /kg in three days and continue with oral prednisolone at a dose of 1 mg / kg for three days . Echocardiographist is not aware of the type of treatment.
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Participants/Inclusion and exclusion criteria
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Including criteria :1- age of 6 month to 5 years old 2-complete and incomplete Kawasaki disease definition according to AHA .
Excluding criteria: complicated cases( MAS), recurrent Kawasaki, previous coronary artery abnormality , congestive heart failure, chronic renal failure, prednisolone sensitization, active viral infection of zoster, or Exposure to varicella in the past 21 days if not immunized, injecting oral, intravenous or muscular corticosteroid current> 3 days in the last 7 days, history of severe reaction to the preparation of any human globulin product, registration in another study possible It will affect the effects of treatment, effectiveness or follow-up.
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Intervention groups
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After entering the study, patients were randomly divided into two groups: IVIG2g / kg, aspirin and 3-day intravenous pulsomethyl prednisolone at a dose of 30mg / kg, and continued treatment with oral prednisolone 1mg / kg for 3 days.
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Main outcome variables
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fever duration, frequency of symptoms,mean CRP inflammatory factors,frequency of CAA,severity of CAA
General information
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Reason for update
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Modification of inclusion criteria
With the highest prevalence of coronary involvement below the age of six months, the minimum age of inclusion criteria changed from one year to six months.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181202041817N1
Registration date:
2019-08-26, 1398/06/04
Registration timing:
registered_while_recruiting
Last update:
2020-01-06, 1398/10/16
Update count:
1
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Registration date
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2019-08-26, 1398/06/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-19, 1397/11/30
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Expected recruitment end date
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2020-02-19, 1398/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of primary intravenous methyl prednisolone pulse treatment in the prevention of coronary artery abnormality in children with Kawasaki disease
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Public title
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The effect of corticosteroid on the treatment of Kawasaki
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Kawasaki disease definition according to American Heart Assosiation (AHA): Complete Kawasaki disease : Fever for more than 5 days plus at least four of the following clinical signs : Bilateral conjunctival injection, Changes in the oropharyngeal mucous membranes, including one or moreof injected and/or fissured lips, strawberry tongue, injected pharynx ,Changes in the peripheral extremities, including erythema and/or edema of the hands and feet (acute phase) or periungual desquamation (convalescent phase), Polymorphous rash, Cervical lymphadenopathy with at least one node >1.5 cm
Incomplete Kawasaki : Fever for more than 5 days plus fewer than 4 of the principal clinical findings, and compatible laboratory or echocardiographic findings.
Exclusion criteria:
Complicated disease( Macrophage Activating Syndrome)
Patients with frequent KD
Patients with Coronary Artery Abnormality have already been approved
Congestive Heart Failure
Chronic renal failure
Sensitization to Methyl Prednisolone or Prednisolone
Active viral viral zoster infection; or exposure to Varicella in the past 21 days if not safe
Injection of Oral, Intravenous or Muscular Corticosteroids> 3 days in the last 7 days
History of severe reaction to the preparation of any human globulin product
Registering in another study that may affect the effects of treatment, effectiveness, or follow-up.
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Age
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From 6 months old to 5 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done in a sealed envelope.Thirty envelopes containing the word of IVIG and thirty envelopes containing the word of methylprednisolone pulse are inserted into the box. , Based on which type of the envelope comes out , treatment is selected at random.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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One permanent cardiologist performs all echocardiography, which does not have any information about the type of treatment
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-27, 1398/01/07
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Ethics committee reference number
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IR.TUMS.CHMC.REC.1398.008
Health conditions studied
1
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Description of health condition studied
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Kawasaki disease
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ICD-10 code
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M30.3
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ICD-10 code description
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Mucocutaneous lymph node syndrome [Kawasaki]
Primary outcomes
1
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Description
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Coronary Artery abnormality in the Kawasaki disease
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Timepoint
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Echocardiography is performed at least three times (immediately at the beginning of the diagnosis, two weeks and two months after the onset of the disease).
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Method of measurement
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Echocardiography
2
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Description
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Reduction of Coronary Artery abnormality in the Kawasaki disease
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Timepoint
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Echocardiography is performed at least three times (immediately at the beginning of the diagnosis, two weeks and two months after the onset of the disease).
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Method of measurement
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Echocardiography
Secondary outcomes
1
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Description
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The severity of coronary artery disease
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Timepoint
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At least three times (immediately at the start of the diagnosis, two weeks and two months after the onset of the disease)
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Method of measurement
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Echocardiography
2
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Description
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prevalence of coronary artery involvement
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Timepoint
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before intervention, 14 and 60 days after onset of treatment.
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Method of measurement
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echocardiography
Intervention groups
1
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Description
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Intervention group: Aspirin 30 mg / kg and intravenous methyl prednisolone pulse at 30 mg / kg in three days .Within 12 hours after the first dose of the steroid pulse, if the temperature return to normal and CRP drops to less than half before treatment, it is considered as response to treatment and treatment will continue with oral prednisolone at a dose of 1 mg / kg and if the temperature do not return to normal and CRP drops to less than half before treatment, it is considered as failure of treatment and will be treated with standard IVIG treatment similar to the control group.
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Category
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Treatment - Drugs
2
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Description
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Control group: Treatment with IVIG at 2g / kg and aspirin at 30 mg / kg
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Coronary involvement information
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Researchers working in academia and academia
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Under which criteria data/document could be used
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spss
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From where data/document is obtainable
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ziaee@tums.ac.ir
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What processes are involved for a request to access data/document
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Request by email
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Comments
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