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: a Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05539027

Enrollment

140

Registered

2022-09-14

Start date

2022-09-20

Completion date

2024-10-31

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Brief 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.

Detailed 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.

Interventions

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

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

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

patients will receive BCAA enriched solution (Aminoleban)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)	5 days of treatment	Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026