跳至主要内容
临床试验/NCT03007537
NCT03007537终止不适用

The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
101
试验地点
1
主要终点
Number of Participants With Acute Kidney Injury

研究概览

简要总结

To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney injury, and trying to provide evidence for protecting the renal function and improving the prognosis for patients after cardiac surgery.

详细描述

Patients meet the inclusion criteria and agree to sign an informed consent will be randomly assigned into the control group or erythropoietin group.Interventions will be applied 1 day(24hrs) before the cardiac surgery. Blood and Urine samples will be collected after the surgery. By using the criterion given by KDIGO2012 and testing the biomarkers for acute kidney injury, we hope to find out if there is an association between erythropoietin administration and the occurence of acute kidney injury.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Preoperative hemoglobin<130g/L;
  • Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;
  • Volunteers with informed consent.

排除标准

  • Patients combined with infection;
  • Patients with end-stage renal disease and undergoing renal replacement therapy
  • Patients with the history of thromboembolism;
  • Patients with malignant tumor and undergoing chemotherapy;
  • Patients with unmanageable hypertension (systolic pressure>200 mmHg or diastolic pressure>110mmHg);
  • Patients allergic to erythropoietin;
  • Patients injected erythropoietin within 2 weeks.

研究组 & 干预措施

control group

Placebo Comparator

0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery

干预措施: 0.9% sodium chloride (Drug)

control group

Placebo Comparator

0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery

干预措施: cardiac surgery (Procedure)

Erythropoietin group

Experimental

10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery

干预措施: Erythropoietin (Drug)

Erythropoietin group

Experimental

10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery

干预措施: cardiac surgery (Procedure)

结局指标

主要结局

Number of Participants With Acute Kidney Injury

时间窗: 7 days

Occurrence of acute kidney injury according to KDIGO guideline

次要结局

  • Number of Participants With Renal Replacement Therapy(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验