Clinical trial NCT03892447: The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Children AKI Patients
Keywords: AKI
Child
Alprostadil
Sodium Ferulate
Dopamine
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Provide informed consent signed and dated by participants and/or their guardians
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:

1. prerenal or postrenal failure
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

Primary outcomes:
measure: Serum creatinin
timeFrame: baseline, 52 weeks
measure: eGFR
timeFrame: baseline, 52 weeks
measure: Urine volume
timeFrame: baseline, 52 weeks
Secondary outcomes:
measure: Urinary markers：White Blood Cell (WBC)
timeFrame: baseline, 52 weeks
measure: Urinary markers：Red Blood Cell (RBC)
timeFrame: baseline, 52 weeks
measure: Urinary markers：Urine protein
timeFrame: baseline, 52 weeks
measure: Serum urea
timeFrame: baseline, 52 weeks
measure: Serum Cystatin
timeFrame: baseline, 52 weeks
measure: Three dimensional(3D) color ultrasound Imaging
timeFrame: baseline, 52 weeks
measure: Blood pressure
timeFrame: baseline, 52 weeks
measure: Duration of hospital stays
timeFrame: baseline, 52 weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenjing Hospital
state: Liaoning
Study officials:
References: