An observational study in Hepatic Encephalopathy, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-11.
Sponsored by Assiut University · Observational
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.
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.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 58 observational studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients known to be cirrhotic admitted at Al-Rajhi liver hospital at Assiut university by hepatic encephalopathy
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Exclusion Criteria:
Neurological conditions that make the assessment of hepatic encephalopathy difficult
Gastrointestinal Bleeding requiring blood transfusion
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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 for 3 days
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
Drug: Aminoleban (8% amino acids infusion)
Each 1000ml of AMINOLEBAN contains: Aminoacetic acid - 9.0 g L-alanine -- 7.5 g L-arginine Hydrochloride (HCl) -- 7.3 g (L-arginine equivalent) -- (6.0 g) L-cysteine HCl monohydrate -- 0.4 g (L-cysteine equivalent) -- (0.3 g) L-histidine HCl monohydrate -- 3.2 g (L-histidine equivalent)-- (2.4 g) L-isoleucine -- 9.0 g L-leucine -- 11.0 g L-Lysine HCl -- 7.6 g (L-lysine equivalent) -- (6.1 g) L-methionine -- 1.0 g L-phenylalanine -- 1.0 g L-proline -- 8.0 g L-serine -- 5.0 g L-threonine -- 4.5 g L-tryptophan -- 0.7 g L-valine -- 8.4 g Water for injection q.s -- 1000 m
Amino acid profile in hepatic encephalopathy
Measuring the level of plasma different free amino acids in hepatic encephalopathy patients
Time frame: 24 hours
Relation between amino acids and nutrition
Study the relation between amino acid profile and nutritional status of hepatic encephalopathy patients.
Time frame: 24 hours
IV Amino acids infusion effect
Investigating the prognosis and in-hospital mortality of patients with hepatic encephalopathy following the use of IV Amino acids infusion for 3 days
Time frame: up to 1 week
No study locations are listed for this record.
Start is estimated for Dec 2017; primary completion for Dec 2018, 12 months later.
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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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