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

Phase 4

• Conditions: Children AKI Patients
• Interventions: Drug: Sodium Ferulate; Drug: Alprostadil; Drug: Dopamine

• Registration Number: NCT03892447
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-27
• Last Update Posted: 2019-03-27
• Study Start: 2019-08-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Ferulate	Sodium Ferulate	Sodium Ferulate 2\~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Alprostadil	Alprostadil	Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Alprostadil	Dopamine	Alprostadil 0.2\~0.3ug/kg.h,iv,1h/d,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Sodium Ferulate	Dopamine	Sodium Ferulate 2\~6mg/kg.d,iv,14d; Dopamine3～5 ug/kg·min,iv,3 h/d,14d

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Blood pressure	baseline, 52 weeks
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.
Serum urea	baseline, 52 weeks	Obtained through renal function test.
Urinary markers：Urine protein	baseline, 52 weeks	Obtained through routine urine examination.
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.
Duration of hospital stays	baseline, 52 weeks

Trial Locations

Locations (1)

Shenjing Hospital; 🇨🇳 Shenyang, Liaoning, China