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临床试验/NCT03306498
NCT03306498Unknown不适用

Plasma Free Amino Acids in Patients With Hepatic Encephalopathy and Its Impact on Disease Outcomes.

Assiut University0 个研究点目标入组 100 人开始时间: 2017年12月15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
入组人数
100
主要终点
Amino acid profile in hepatic encephalopathy

研究概览

简要总结

This is study to investigate the plasma free amino acids profile in patients with decompensated liver cirrhosis and hepatic encephalopathy and its relation to the nutritional state of these patients.

  • To investigate the plasma free amino acids relation to the nutritional state of patients with liver cirrhosis and hepatic encephalopathy.
  • To determine the effectiveness, cost, cost-benefit and in-hospital prognosis of branched chain amino acid (BCAA) infusion as an adjuvant to conventional mainstay therapy in the treatment of hepatic encephalopathy due to liver cirrhosis.
  • To determine the effectiveness of branched chain amino acid (BCAA) infusion on improving amino acid imbalance and Fischer ratio (Branched chain amino acids/Aromatic amino acids ratio).

详细描述

Alterations in amino acid profiles observed in patients with liver cirrhosis are very specific and markedly differ from those observed in other disorders..

Until present time the treatment of hepatic encephalopathy is mainly aimed at reducing the production and intestinal absorption of ammonia by antibiotics and non-absorbable disaccharides, although the available data indicate a low success rate of these strategies.

Beneficial effects of branched chain amino acids supplementation (BCAA) may be more pronounced in patients with marked depression of BCAA and/or low Branched chain amino acids/Aromatic amino acids (BCAA/AAA) ratio in extracellular fluid.

It also may be suggested that the beneficial effect of long term intake of BCAA on hepatic encephalopathy demonstrated in clinical studies is related to improved muscle mass and nutritional status.

The current recommendation only includes oral BCAA to patients with liver disease who are intolerant to standard protein intake.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient has decompensated liver cirrhosis
  • Patient has overt hepatic encephalopathy

排除标准

  • Protein losing enteropathy.
  • Neurological conditions that make the assessment of hepatic encephalopathy difficult
  • Parkinson's disease
  • Alzheimer's disease
  • Concomitant stroke
  • Gastrointestinal Bleeding requiring blood transfusion

研究组 & 干预措施

hepatic encephalopathy patients-amino

The following will be administered to this group of patients rifaximin 550 tablets b.i.d Lactulose syrup 5cm b.i.d Enema b.i.d plus Aminoleban (8% amino acids infusion) b.i.d for 3 days

干预措施: Aminoleban (8% amino acids infusion) (Drug)

结局指标

主要结局

Amino acid profile in hepatic encephalopathy

时间窗: 24 hours

Measuring the level of plasma different free amino acids in hepatic encephalopathy patients

次要结局

  • Relation between amino acids and nutrition(24 hours)
  • IV Amino acids infusion effect(up to 1 week)

研究者

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

Mahmoud Hamed Goda

Specialist

Assiut University

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