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临床试验/NCT03102021
NCT03102021已完成2 期

The Effect of High Dose Erythropoietin in Acute Renal Failure

North Texas Veterans Healthcare System1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年3月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
days of acute renal failure

研究概览

简要总结

The purpose of this study is to determine if the use of erythropoietin when used in high dose during acute kidney injury can decrease the number of days of kidney injury.

详细描述

Acute kidney injury is associated with increased morbidity. The most common injury to the kidney occurs during hospitalization with either ischemic or nephrotoxic insult to the kidney. This can prolong hospitalization and depending on the severity of the insult result in permanent decreased kidney function. Recent studies in animals have suggested benefits of using erythropoietin in high doses at time of kidney injury with eividence for less injury in the kidney tissue of those animals who received treatment compared to those animals that received only saline. Limited human data also suggests that use of high dose erythropoietin at the time of stroke can decrease the extent of brain injury. In addition cardiac cell culture studies also have shown decrease in cell injury with use of erythropoietin. These studies have prompted us to evaluate if admininstering erythropoietin to those with onset of acute kidney injury during their hospitalization may benefit from this intervention. This pilot study then evaluates that use of high dose erythropoietin administed daily over 3 days in patients with acute kidney injury on whether the days spent in renal failure are less than those who will receive no study medication. Those patients with kidney failure from either ischemic or nephrotoxic insult and no other contraindication to erythropoietin use will be considered for the study. Informed consent is obtained from the patient or next of kin

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age equal or greater than 21 yo
  • acute neprhotoxic or ischemic kidney injury, acute tubular necrosis

排除标准

  • no active or current malignancies
  • not actively receiveing epo
  • GFR less than 60 ml/min
  • unable to provide informed consent
  • contraindication to erythropoietin use

研究组 & 干预措施

1

Active Comparator

erythropoeitin

干预措施: erythropoietin (Drug)

2

Placebo Comparator

saline placebo

干预措施: saline (Drug)

结局指标

主要结局

days of acute renal failure

时间窗: 28 days

次要结局

  • days of hospitalization(60 days)

研究者

发起方
North Texas Veterans Healthcare System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Devasmita Dev, MD

Principal Investigator

North Texas Veterans Healthcare System

研究点 (1)

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