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IRCT20181202041817N1 IRCT 2019-08-26 Tehran University of Medical Sciences The effect of corticosteroid on the treatment of Kawasaki Evaluation of primary intravenous methyl prednisolone pulse treatment in the prevention of coronary artery abnormality in children with Kawasaki disease 2019-02-19 anticipated 60 Complete https://irct.ir/trial/35607 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: One permanent cardiologist performs all echocardiography, which does not have any information about the type of treatment. 3 Kawasaki disease. Intervention 1: 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. Intervention 2: Control group: Treatment with IVIG at 2g / kg and aspirin at 30 mg / kg. Yes - There is a plan to make this available What will be shared: Coronary involvement information When: Start the access period 6 months after printing the results To whom: Researchers working in academia and academia Conditions: spss Where to obtain: ziaee@tums.ac.ir How to obtain: Request by email Comments:
public Dr. Vahid Ziaee
Tehran, Keshavarz Blvd, Doctor Gharib St., No. 62, Children's Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6659 5522 ziaee@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Vahid Ziaee
Tehran, Keshavarz Blvd, Doctor Gharib St., No. 62, Children's Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6659 5522 ziaee@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 6 months 5 years Both 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. M30.3 Mucocutaneous lymph node syndrome [Kawasaki] Treatment - Drugs Treatment - Drugs 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. Control group: Treatment with IVIG at 2g / kg and aspirin at 30 mg / kg Coronary Artery abnormality in the Kawasaki disease. Timepoint: 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). Method of measurement: Echocardiography. Reduction of Coronary Artery abnormality in the Kawasaki disease. Timepoint: 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). Method of measurement: Echocardiography. The severity of coronary artery disease. Timepoint: At least three times (immediately at the start of the diagnosis, two weeks and two months after the onset of the disease). Method of measurement: Echocardiography. Prevalence of coronary artery involvement. Timepoint: before intervention, 14 and 60 days after onset of treatment. Method of measurement: echocardiography. Tehran University of Medical Sciences Approved 2019-03-27 National Ethics Committee for Biomedical Research Tehran, Keshavarz Blvd, Doctor Gharib St., No. 62, Children's Medical Center Tehran Tehran Iran (Islamic Republic of)