The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury
NCT ID: NCT03892447
Last Updated: 2019-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2019-08-01
2021-12-31
Brief Summary
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Dopamine is a vasodilating drug that in small doses improves renal circulation. Alprostadil have been used in chronic arterial occlusion and Sodium Ferulate in ischemic cerebral vascular disease,they have a similar therapeutic effect of anti-platelet aggregation and vasodilation. Recent research shows that alprostadil might be associated with a significant reduction in postcontrast Scr, blood urine nitrogen (BUN) and Cystatin C (CysC) level and decrease the incidence of contrast-induced nephropathy.The investigators speculate that Alprostadil,Sodium Ferulate and dopamine would be effective in treating AKI in children.
This is a prospective, multicenter, randomized, double-blind, 52-week study. The purpose of this study is to evaluate the comparative effectiveness and safety of Alprostadil,Sodium Ferulate and dopamine in improving the outcome of AKI in children.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alprostadil
Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Alprostadil
Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d
Dopamine
Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Sodium Ferulate
Sodium Ferulate 2\~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Sodium Ferulate
Sodium Ferulate 2\~6mg/kg.d,iv,14d
Dopamine
Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Interventions
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Alprostadil
Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d
Sodium Ferulate
Sodium Ferulate 2\~6mg/kg.d,iv,14d
Dopamine
Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Eligibility Criteria
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Inclusion Criteria
2. male or female, Asian.
3. Aged from 1 to 18 years.
4. Patients meet the AKI diagnosis criteria of 2012 Kidney Disease: Improving Global Outcome (SKDIGO) Guideline
Exclusion Criteria
2. Patients need renal replacement therapy
3. Patients with hemorrhagic disorders
4. Patients in shock
5. Patients with multiple organ failure
6. History of Alprostadil or Sodium Ferulate or dopamine sensitivity
7. Patients with heart failure
8. Patients with peptic ulcer
9. Patients with glaucoma
10. Patients with interstitial pneumonia
1 Year
18 Years
ALL
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Yubin Wu
Professor
Locations
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Shenjing Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Related Links
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2012 SKDIGO Guideline
Other Identifiers
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SJES001
Identifier Type: -
Identifier Source: org_study_id
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