NCT03892447

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

March 25, 2019

Last Update Submit

March 25, 2019

Conditions

Children AKI Patients

Keywords

AKIChildAlprostadilSodium FerulateDopamine

Outcome Measures

Primary Outcomes (3)

  • Serum creatinin

    The change of Serum creatinin from baseline after the use of the study drug.

    baseline, 52 weeks

  • eGFR

    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

    The change of urine volume from baseline after the use of the study drug.

    baseline, 52 weeks

Secondary Outcomes (8)

  • Urinary markers：White Blood Cell (WBC)

    baseline, 52 weeks

  • Urinary markers：Red Blood Cell (RBC)

    baseline, 52 weeks

  • Urinary markers：Urine protein

    baseline, 52 weeks

  • Serum urea

    baseline, 52 weeks

  • Serum Cystatin

    baseline, 52 weeks

  • +3 more secondary outcomes

Study Arms (2)

Alprostadil

EXPERIMENTAL

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

Drug: AlprostadilDrug: Dopamine

Sodium Ferulate

ACTIVE COMPARATOR

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

Drug: Sodium FerulateDrug: Dopamine

Interventions

AlprostadilDRUG

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

Alprostadil
Sodium FerulateDRUG

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

Sodium Ferulate
DopamineDRUG

Dopamine3～5 ug/kg·min,iv,3 h/d,14d

AlprostadilSodium Ferulate

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • prerenal or postrenal failure
  • Patients need renal replacement therapy
  • Patients with hemorrhagic disorders
  • Patients in shock
  • Patients with multiple organ failure
  • History of Alprostadil or Sodium Ferulate or dopamine sensitivity
  • Patients with heart failure
  • Patients with peptic ulcer
  • Patients with glaucoma
  • Patients with interstitial pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related Links

MeSH Terms

Interventions

Alprostadilferulic acidDopamine

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological FactorsBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Yubin Wu, Professor

CONTACT

18940257958wuyb001@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 27, 2019

Study Start

August 1, 2019

Primary Completion

April 30, 2021

Study Completion

December 31, 2021

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

CN(1)