A 52-week Multicenter, Randomized, Double-blind, Prospective Study to Evaluate Comparative Effectiveness and Safety of Alprostadil Injection,Sodium Ferulate and Dopamine Injection in Pediatric Acute Kidney Injury
Overview
- Phase
- Phase 4
- Intervention
- Alprostadil
- Conditions
- Children AKI Patients
- Sponsor
- Shengjing Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Serum creatinin
- Last Updated
- 7 years ago
Overview
Brief Summary
Acute kidney injury (AKI) is a pervasive clinical event in children.It has been independently associated with prolonged hospital stays, risk of in-hospital death and future progression to chronic kidney disease. Except for removal of nephrotoxic agents and optimization of supportive care,there are still no other effective therapeutic options recommended by recent guidelines. Renal ischemia is the main mechanism of AKI, the improving microcirculation therapy would be the effective management to improve the outcome of AKI in children.
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.
Detailed Description
This study aims to explore the effective treatment of pediatric AKI and improve the outcome. It is a 52-week multicenter, randomized, double-blind,prospective study to evaluate comparative effectiveness and safety of alprostadil injection,sodium ferulate and dopamine injection. This study plans to recruit 8 to 10 centers, with 300 participants randomly divided into 3 groups and given respectively Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d,Sodium Ferulate2\~6mg/kg.d,iv,14d,Dopamine3\~5ug/kg .min,iv,3h/d,14d.Time of outcome measurement is 1w,2w,4w,24w,52w. Primary Outcome Measures is The change of Serum creatinin from baseline, estimated glomerular filtration rate (eGFR) and urine volume in the participants after the use of the study drug.
Investigators
Yubin Wu
Professor
Shengjing Hospital
Eligibility Criteria
Inclusion Criteria
- •Provide informed consent signed and dated by participants and/or their guardians
- •male or female, Asian.
- •Aged from 1 to 18 years.
- •Patients meet the AKI diagnosis criteria of 2012 Kidney Disease: Improving Global Outcome (SKDIGO) Guideline
Exclusion Criteria
- •prerenal or postrenal failure
- •Patients need renal replacement therapy
- •Patients with hemorrhagic disorders
- •Patients in shock
- •Patients with multiple organ failure
- •History of Alprostadil or Sodium Ferulate or dopamine sensitivity
- •Patients with heart failure
- •Patients with peptic ulcer
- •Patients with glaucoma
- •Patients with interstitial pneumonia
Arms & Interventions
Alprostadil
Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Intervention: Alprostadil
Alprostadil
Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Intervention: Dopamine
Sodium Ferulate
Sodium Ferulate 2\~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Intervention: Sodium Ferulate
Sodium Ferulate
Sodium Ferulate 2\~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Intervention: Dopamine
Outcomes
Primary Outcomes
Serum creatinin
Time Frame: baseline, 52 weeks
The change of Serum creatinin from baseline after the use of the study drug.
eGFR
Time Frame: baseline, 52 weeks
The change of eGFR from baseline after the use of the study drug. eGFR (ml/min/1.73m2)=K×L/SCr. L: Height(cm), SCr: serum creatinin (umol/L),K:36.5
Urine volume
Time Frame: baseline, 52 weeks
The change of urine volume from baseline after the use of the study drug.
Secondary Outcomes
- Urinary markers：White Blood Cell (WBC)(baseline, 52 weeks)
- Urinary markers：Red Blood Cell (RBC)(baseline, 52 weeks)
- Three dimensional(3D) color ultrasound Imaging(baseline, 52 weeks)
- Serum urea(baseline, 52 weeks)
- Urinary markers：Urine protein(baseline, 52 weeks)
- Blood pressure(baseline, 52 weeks)
- Serum Cystatin(baseline, 52 weeks)
- Duration of hospital stays(baseline, 52 weeks)