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

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ClinicalTrials.gov Identifier: NCT03892447
Recruitment Status : Unknown
Verified March 2019 by Yubin Wu, Shengjing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yubin Wu, Shengjing Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Serum creatinin [ Time Frame: baseline, 52 weeks ]
    The change of Serum creatinin from baseline after the use of the study drug.

  2. 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

  3. Urine volume [ Time Frame: baseline, 52 weeks ]
    The change of urine volume from baseline after the use of the study drug.


Secondary Outcome Measures :
  1. Urinary markers：White Blood Cell (WBC) [ Time Frame: baseline, 52 weeks ]
    Obtained through routine urine examination.

  2. Urinary markers：Red Blood Cell (RBC) [ Time Frame: baseline, 52 weeks ]
    Obtained through routine urine examination.

  3. Urinary markers：Urine protein [ Time Frame: baseline, 52 weeks ]
    Obtained through routine urine examination.

  4. Serum urea [ Time Frame: baseline, 52 weeks ]
    Obtained through renal function test.

  5. Serum Cystatin [ Time Frame: baseline, 52 weeks ]
    Obtained through renal function test.

  6. Three dimensional(3D) color ultrasound Imaging [ Time Frame: baseline, 52 weeks ]
    Size of kidneys,Blood flow of renal arteries.

  7. Blood pressure [ Time Frame: baseline, 52 weeks ]
  8. Duration of hospital stays [ Time Frame: baseline, 52 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892447


Contacts
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Contact: Yubin Wu, Professor 18940257958 wuyb001@163.com

Locations
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China, Liaoning
Shenjing Hospital
Shenyang, Liaoning, China, 110004
Sponsors and Collaborators
Shengjing Hospital
More Information
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Additional Information:

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Responsible Party: Yubin Wu, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03892447    
Other Study ID Numbers: SJES001
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yubin Wu, Shengjing Hospital:
AKI
Child
Alprostadil
Sodium Ferulate
Dopamine
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ferulic acid
Dopamine
Alprostadil
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Anticoagulants
Antihypertensive Agents
Cholagogues and Choleretics
Gastrointestinal Agents
Free Radical Scavengers