Hepatic Encephalopathy Clinical Trial
Official title:
Plasma Free Amino Acids in Patients With Hepatic Encephalopathy and Its Impact on Disease Outcomes.
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).
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.
The rationale for this limitation is based on the fact that in the mentioned randomized
trials, hepatic encephalopathy was not part of the inclusion criteria. Additionally, the
positive effect was difficult to interpret as it was observed on compound end points, which
combine survival, hospitalization, and cirrhosis complications. From these results, it is not
possible to ascertain the role of BCAA in hepatic encephalopathy, which patients benefit and
to what extent .
For this reason, the investigators designed this study to assess effectiveness of BCAA in
improving clinical, nutritional and laboratory status of these patients.
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