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

March 25, 2019 updated by: Yubin Wu, Shengjing Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yubin Wu, Professor
  • Phone Number: 18940257958
  • Email: wuyb001@163.com

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shenjing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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: Dopamine
Dopamine3～5 ug/kg·min,iv,3 h/d,14d
Drug: Sodium Ferulate
Sodium Ferulate 2~6mg/kg.d,iv,14d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum creatinin
Time Frame: baseline, 52 weeks
The change of Serum creatinin from baseline after the use of the study drug.
baseline, 52 weeks
eGFR
Time Frame: 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
baseline, 52 weeks
Urine volume
Time Frame: baseline, 52 weeks
The change of urine volume from baseline after the use of the study drug.
baseline, 52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2019

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (ACTUAL)

March 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJES001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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