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NCT Number: NCT05539027

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, 11361, Egypt

About this study

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

  • Normal
  • Mild lack of awareness
  • Lethargic
  • Somnolent but arousable
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

patients will receive branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)

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

Drug

patients will receive BCAA enriched solution (Aminoleban)

Primary outcomes

  1. Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)

    Time frame: 5 days of treatment

    Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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