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

Last updated: November 23, 2024
Sponsor: Ain Shams University
Overall Status: Completed

Phase

4

Condition

Liver Disorders

Vomiting

Hepatic Encephalopathy

Treatment

Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)

Branched-chain amino acids (BCAA), enriched solution (Aminoleban)

Clinical Study ID

NCT05539027
FMASU MS 556/ 2022
  • Ages 21-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with Liver cirrhosis based on clinical, biochemical, radiologicaland/or histopathology.

  • Patients having overt HE, West Haven criteria (WHC) grade III-IV.

Exclusion

Exclusion Criteria:

  • Age < 21 years.

  • Inability to obtain an informed consent from the first degree relative and/orlegally 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 Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)
Phase: 4
Study Start date:
September 20, 2022
Estimated Completion Date:
October 31, 2024

Study 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

  1. Normal

  2. Mild lack of awareness

  3. Lethargic

  4. Somnolent but arousable

  5. 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.

Connect with a study center

  • Ain-Shams University Hospitals

    Cairo, 11361
    Egypt

    Site Not Available

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