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临床试验/NCT02628106
NCT02628106已完成4 期

Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients

West China Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
21
试验地点
1
主要终点
the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI

研究概览

简要总结

The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 (lipo-PGE1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were included. All patients were divided into two groups: diabetic nephropathy(DN) and CKD without diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and after lipo-PGE1 administration to acquire bilateral renal cortical R2*(CR2*) and medullary R2* (MR2*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.

详细描述

R2* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks, Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. The R2* map was windowed from 0 to 60 s-1.

Regions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. Three ROIs were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral cortex and medulla. To prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. Thereafter, assuming the tests were coincident, the results were the averaged.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of chronic kidney disease

排除标准

  • Intolerance to lipo-PGE1, contraindication for MRI, concurrent urinary tract infection, acute kidney injury, acute cardiovascular and cerebrovascular complications and diabetic emergencies, with the use of corticosteroid and diureses.

研究组 & 干预措施

Lipo-prostaglandin E1

Experimental

all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.

干预措施: Lipo-PGE1 (Drug)

结局指标

主要结局

the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI

时间窗: baseline and after 14days of lipo-PGE1 intravenously

the R2\* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline,R2\* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhicheng Li

A graduate student

West China Hospital

研究点 (1)

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