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临床试验/NCT05076318
NCT05076318已完成不适用

Dysregulated Urea-synthesis at Terminal Uremia

University of Aarhus2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Urea synthesis rate during alanine infusion

研究概览

简要总结

This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > or equal to 18 years
  • Chronic hemodialysis during 3 months
  • Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"

排除标准

  • Active infection
  • Conditions with vomiting or diarrhea
  • Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included.
  • Liver disease
  • Vessels on the upper extremities not suited for cannulation
  • Prednisolone treatment during the last 8 weeks
  • Pregnancy
  • BMI > or equal to 30 or < or equal to 18
  • Physically or mentally condition that does not allow the project to be completed
  • Language-difficulties that does not allow the project to be completed

研究组 & 干预措施

Alanine-infusion

Experimental

Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis

干预措施: Aminoacid, alanine-infusion (Other)

结局指标

主要结局

Urea synthesis rate during alanine infusion

时间窗: 4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion

Change in the synthesis of urea during a 3 hour period of alanine-infusion in pre and post hemodialysis patients. We will use a validated method named functional hepatic nitrogen clearance (FHNC) to evaluate the synthesis of urea. FHNC is calculated using the linear relation between urea nitrogen synthesis rate and blood-amino acid which is measured every hour. An estimated group of 10 dialysis patients will be included and compared to a clinical healthy group. The healthy group has also received alanine infusion and blood samples of urea and amino-acids has likewise been measured for every hour of infusion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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