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临床试验/NCT02059356
NCT02059356终止不适用

Prevalence of High Ammonia Levels in Patients With Cognitive Impairment. Does Treatment Help?

Duke University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
Change in blood ammonia level

研究概览

简要总结

The purpose and objective of this study is to determine the prevalence of elevated ammonia levels in subjects with cognitive impairment, and to observe if treating the cause of the elevated ammonia level improves mental status. This study does not include any imaging, treatment,or interventions, other than the blood draws. The blood draws will be taken to assess blood ammonia level and liver function. If the the ammonia level is not elevated, no further lab draws will occur. If the ammonia level is elevated, liver function is normal, and a cause for the high ammonia level is revealed with a plan for clinical treatment by the subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3 months after treatment. The main risk to subjects is related to the blood draw (i.e. momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a potential loss of confidentiality. A paired student t test will be done with the two later blood to compare objective data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • cognitive decline (suspected or documented)
  • able to get blood drawn

排除标准

  • liver disease/cirrhosis

结局指标

主要结局

Change in blood ammonia level

时间窗: Baseline, Pretreatment and 3 months after treatment

次要结局

  • Change in mini-status examination(Prior to treatment and 3 months after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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