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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
Sponsor:
Information provided by (Responsible Party):
Mahmoud Hamed Goda, Assiut University

Brief Summary:

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)

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Free Amino Acids in Patients With Hepatic Encephalopathy and Its Impact on Disease Outcomes.
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Amino acid profile in hepatic encephalopathy [ Time Frame: 24 hours ]
    Measuring the level of plasma different free amino acids in hepatic encephalopathy patients


Secondary Outcome Measures :
  1. Relation between amino acids and nutrition [ Time Frame: 24 hours ]
    Study the relation between amino acid profile and nutritional status of hepatic encephalopathy patients.

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients known to be cirrhotic admitted at Al-Rajhi liver hospital at Assiut university by hepatic encephalopathy
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Protein losing enteropathy.
  2. Neurological conditions that make the assessment of hepatic encephalopathy difficult

    1. Parkinson's disease
    2. Alzheimer's disease
    3. Concomitant stroke
  3. Gastrointestinal Bleeding requiring blood transfusion


Information from the National Library of Medicine

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


Contacts
Contact: mahmoud HG Abdel-Rahman, specialist +201003149449 mahmoud_goda87@yahoo.com
Contact: Sahar M Hassany, A.Professor +201010431017 saharhassany@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Study Chair: Ahmad H Salem, MD Assiut University
Principal Investigator: Mahmoud HG Abdel-Rahman, Master Assiut University
Study Director: Sahar M Hassany Assiut University

Publications:
Responsible Party: Mahmoud Hamed Goda, Specialist, Assiut University
ClinicalTrials.gov Identifier: NCT03306498     History of Changes
Other Study ID Numbers: amino acids in liver cirrhosis
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mahmoud Hamed Goda, Assiut University:
plasma free amino acids

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases