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
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serum creatinin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alprostadil
Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
干预措施: Alprostadil (Drug)
Alprostadil
Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
干预措施: Dopamine (Drug)
Sodium Ferulate
Sodium Ferulate 2~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
干预措施: Sodium Ferulate (Drug)
Sodium Ferulate
Sodium Ferulate 2~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
干预措施: Dopamine (Drug)
结局指标
主要结局
Serum creatinin
时间窗: baseline, 52 weeks
The change of Serum creatinin from baseline after the use of the study drug.
eGFR
时间窗: 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
时间窗: baseline, 52 weeks
The change of urine volume from baseline after the use of the study drug.
次要结局
- 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)