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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Hepatic Encephalopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05539027

FMASU MS 556/ 2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Group 1 (Treatment group)

Active Comparator group

Treatment:

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

Group 2 (Control group)

Active Comparator group

Treatment:

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