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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d
Sodium Ferulate 2\~6mg/kg.d,iv,14d
Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Shenjing Hospital
Shenyang, Liaoning, China
Serum creatinin
The change of Serum creatinin from baseline after the use of the study drug.
Time frame: baseline, 52 weeks
eGFR
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
Time frame: baseline, 52 weeks
Urine volume
The change of urine volume from baseline after the use of the study drug.
Time frame: baseline, 52 weeks
Urinary markers：White Blood Cell (WBC)
Obtained through routine urine examination.
Time frame: baseline, 52 weeks
Urinary markers：Red Blood Cell (RBC)
Obtained through routine urine examination.
Time frame: baseline, 52 weeks
Urinary markers：Urine protein
Obtained through routine urine examination.
Time frame: baseline, 52 weeks
Serum urea
Obtained through renal function test.
Time frame: baseline, 52 weeks
Serum Cystatin
Obtained through renal function test.
Time frame: baseline, 52 weeks
Three dimensional(3D) color ultrasound Imaging
Size of kidneys,Blood flow of renal arteries.
Time frame: baseline, 52 weeks
Blood pressure
Time frame: baseline, 52 weeks
Duration of hospital stays
Time frame: baseline, 52 weeks
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