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

Phase 4

Completed

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA); Drug: Branched-chain amino acids (BCAA), enriched solution (Aminoleban)

• Registration Number: NCT05539027
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Study Start: 2022-09-20
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-23
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Treatment group)	Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)	-
Group 2 (Control group)	Branched-chain amino acids (BCAA), enriched solution (Aminoleban)	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt