Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Methylprednisolone group In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d) |
Drug: Methylprednisolone
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
Drug: other basic supportive treatment
Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day
Low molecular weight heparin calcium 50IU/kg.d
|
| Active Comparator: IVIG group In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d) |
Drug: IVIG
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
Drug: other basic supportive treatment
Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day
Low molecular weight heparin calcium 50IU/kg.d
|
Outcome Measures
Primary Outcome Measures
- sustained abdominal pain relief [3 days after treatment]
no abdominal pain complaint and no abdominal tenderness
Secondary Outcome Measures
- sustained abdominal pain relief [7 days after treatment]
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
- other treatment rather than assigned intervention [4 weeks after treatment]
other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
- tolarable food type [2 weeks after treatment]
what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
- the number of days of taking fasting [At the time of discharge]
the number of days of taking fasting will be counted at the time of discharge
- Drug-related side effects [3 days after treatment]
Side effects associated with methylprednisolone and IVIG will be recorded
- hypertension [7 days after treatment]
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.
- infection [4 weeks after treatment]
different infection types should be specified
- ocular hypertension [7 days after treatment]
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
- steroid-related diabetes [3 days after treatment]
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
- cost of treatment [4 weeks after treatment]
cost of treatment will be obtained from discharge fee list
- The number of days in hospital [at the time of discharge]
The number of days in hospital will be counted at the time of discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
-
both genders
-
age between 2-16 years old
-
IgA vasculitis with gastrointestinal involvement
-
course of disease less than 2 months
-
refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）
Exclusion Criteria:
-
patients with severe sepsis
-
patients with central nervous system infection,
-
patients with severe pneumonia
-
patients with chronic infection (such as EBV, CMV, Tuberculosis)
-
patients complicated by CKD who need renal replacement therapy
-
patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Fudan University | Shanghai | China | ||
| 2 | Children's Hospital of Shanghai | Shanghai | China | ||
| 3 | Shanghai Children's Medical Centre | Shanghai | China |
Sponsors and Collaborators
- Children's Hospital of Fudan University
- Shanghai Children's Hospital
- Shanghai Children's Medical Center
Investigators
- Principal Investigator: Li Sun, MD, Children's Hospital of Fudan University
- Principal Investigator: Wenyan Huang, MD, Shanghai Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- chfuHSP 1.0