IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change
1\. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days
1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d
Children's Hospital of Fudan University
Shanghai, China
RECRUITINGChildren's Hospital of Shanghai
Shanghai, China
NOT_YET_RECRUITINGShanghai Children's Medical Centre
Shanghai, China
NOT_YET_RECRUITINGsustained abdominal pain relief
no abdominal pain complaint and no abdominal tenderness
Time frame: 3 days after treatment
sustained abdominal pain relief
3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment
Time frame: 7 days after treatment
other treatment rather than assigned intervention
other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
Time frame: 4 weeks after treatment
tolarable food type
what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
Time frame: 2 weeks after treatment
the number of days of taking fasting
the number of days of taking fasting will be counted at the time of discharge
Time frame: At the time of discharge
Drug-related side effects
Side effects associated with methylprednisolone and IVIG will be recorded
Time frame: 3 days after treatment
hypertension
systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor.
Time frame: 7 days after treatment
infection
different infection types should be specified
Time frame: 4 weeks after treatment
ocular hypertension
1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg
Time frame: 7 days after treatment
steroid-related diabetes
1\. with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l
Time frame: 3 days after treatment
cost of treatment
cost of treatment will be obtained from discharge fee list
Time frame: 4 weeks after treatment
The number of days in hospital
The number of days in hospital will be counted at the time of discharge
Time frame: at the time of discharge
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