Children AKI Patients Clinical Trial
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
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.
| Status | Not yet recruiting |
| Enrollment | 300 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | April 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 18 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Shenjing Hospital | Shenyang | Liaoning |
| Lead Sponsor | Collaborator |
|---|---|
| Shengjing Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum creatinin | The change of Serum creatinin from baseline after the use of the study drug. | baseline, 52 weeks | |
| Primary | 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 | |
| Primary | Urine volume | The change of urine volume from baseline after the use of the study drug. | baseline, 52 weeks | |
| Secondary | Urinary markers:White Blood Cell (WBC) | Obtained through routine urine examination. | baseline, 52 weeks | |
| Secondary | Urinary markers:Red Blood Cell (RBC) | Obtained through routine urine examination. | baseline, 52 weeks | |
| Secondary | Urinary markers:Urine protein | Obtained through routine urine examination. | baseline, 52 weeks | |
| Secondary | Serum urea | Obtained through renal function test. | baseline, 52 weeks | |
| Secondary | Serum Cystatin | Obtained through renal function test. | baseline, 52 weeks | |
| Secondary | Three dimensional(3D) color ultrasound Imaging | Size of kidneys,Blood flow of renal arteries. | baseline, 52 weeks | |
| Secondary | Blood pressure | baseline, 52 weeks | ||
| Secondary | Duration of hospital stays | baseline, 52 weeks |