The Comparative Effectiveness of Alprostadil,Sodium Ferulate and Dopamine in Pediatric Acute Kidney Injury

Sponsor

Shengjing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03892447

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Children AKI Patients	Drug: Alprostadil Drug: Sodium Ferulate Drug: Dopamine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alprostadil Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d	Drug: Alprostadil Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d Drug: Dopamine Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Active Comparator: Sodium Ferulate Sodium Ferulate 2~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d	Drug: Sodium Ferulate Sodium Ferulate 2~6mg/kg.d,iv,14d Drug: Dopamine Dopamine3～5 ug/kg·min,iv,3 h/d,14d

Arm

Intervention/Treatment

Experimental: Alprostadil

Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d

Drug: Alprostadil

Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d

Drug: Dopamine

Dopamine3～5 ug/kg·min,iv,3 h/d,14d

Active Comparator: Sodium Ferulate

Sodium Ferulate 2~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d

Drug: Sodium Ferulate

Sodium Ferulate 2~6mg/kg.d,iv,14d

Drug: Dopamine

Dopamine3～5 ug/kg·min,iv,3 h/d,14d

Outcome Measures

Primary Outcome Measures

Serum creatinin [baseline, 52 weeks]
The change of Serum creatinin from baseline after the use of the study drug.
eGFR [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 [baseline, 52 weeks]
The change of urine volume from baseline after the use of the study drug.

Secondary Outcome Measures

Urinary markers：White Blood Cell (WBC) [baseline, 52 weeks]
Obtained through routine urine examination.
Urinary markers：Red Blood Cell (RBC) [baseline, 52 weeks]
Obtained through routine urine examination.
Urinary markers：Urine protein [baseline, 52 weeks]
Obtained through routine urine examination.
Serum urea [baseline, 52 weeks]
Obtained through renal function test.
Serum Cystatin [baseline, 52 weeks]
Obtained through renal function test.
Three dimensional(3D) color ultrasound Imaging [baseline, 52 weeks]
Size of kidneys,Blood flow of renal arteries.
Blood pressure [baseline, 52 weeks]
Duration of hospital stays [baseline, 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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