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Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy

Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy

Non Recruiting
21-70 years
All
Phase 4

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Overview

One of the most significant goals of hepatic encephalopathy (HE) treatment is to reduce ammonia levels by lowering its synthesis and enhancing its detoxification which can be achieved by using non-absorbable disaccharides, antibiotics, branched-chain amino acids (BCAA), L-ornithine L-aspartate (LOLA), and probiotics.

LOLA decreases ammonia, therefore, it is presumed to decrease agitated delirium in HE patients and thus decrease their need for other sedatives. On the other hand, BCAA improve mental function in HE patients by increasing the detoxification of ammonia in muscles.

Description

The most often utilized criteria for grading HE are the West Haven criteria (WHC). This grading distinguishes four levels of clinically evident hepatic encephalopathy.

West Haven criteria (WHC): [R]

Stage Consciousness

0. Normal

  1. Mild lack of awareness
  2. Lethargic
  3. Somnolent but arousable
  4. Coma
    REFERENCES

Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy-definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congress of Gastroenterology, Vienna, 1998. Hepatology 2002; 35: 716-21.

Eligibility

Inclusion Criteria:

  • Patients diagnosed with Liver cirrhosis based on clinical, biochemical, radiological and/or histopathology.
  • Patients having overt HE, West Haven criteria (WHC) grade III-IV.

Exclusion Criteria:

  • Age < 21 years.
  • Inability to obtain an informed consent from the first degree relative and/or legally authorized representative.
  • Advanced cardiac or pulmonary disease.
  • Presence of underlying chronic renal failure (serum creatinine > 3 mg/dL).
  • Neurodegenerative disease (including head injury and drug intoxication).
  • Major psychiatric illness.
  • Use of sedatives or antidepressants.
  • Pregnancy or breast-feeding .
  • Hepatocellular carcinoma.
  • Acute on top of chronic liver failure.

Study details
    Hepatic Encephalopathy

NCT05539027

Ain Shams University

20 August 2025

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