Plasma Free Amino Acids in Patients With Hepatic Encephalopathy
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|ClinicalTrials.gov Identifier: NCT03306498|
Recruitment Status : Not yet recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
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).
|Condition or disease||Intervention/treatment|
|Hepatic Encephalopathy||Drug: Aminoleban (8% amino acids infusion)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Plasma Free Amino Acids in Patients With Hepatic Encephalopathy and Its Impact on Disease Outcomes.|
|Anticipated Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||December 15, 2018|
|Estimated Study Completion Date :||February 15, 2019|
hepatic encephalopathy patients
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
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
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 [ Time Frame: 24 hours ]Measuring the level of plasma different free amino acids in hepatic encephalopathy patients
- Relation between amino acids and nutrition [ Time Frame: 24 hours ]Study the relation between amino acid profile and nutritional status of hepatic encephalopathy patients.
- IV Amino acids infusion effect [ Time Frame: up to 1 week ]Investigating the prognosis and in-hospital mortality of patients with hepatic encephalopathy following the use of IV Amino acids infusion for 3 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306498
|Contact: mahmoud HG Abdel-Rahman, firstname.lastname@example.org|
|Contact: Sahar M Hassany, A.Professoremail@example.com|
|Study Chair:||Ahmad H Salem, MD||Assiut University|
|Principal Investigator:||Mahmoud HG Abdel-Rahman, Master||Assiut University|
|Study Director:||Sahar M Hassany||Assiut University|