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

NCT05539027 | Completed Phase 4

• 1 other identifier: FMASU MS 556/ 2022
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

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

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

  5 days of treatment

Study Arms (2)

Group 1 (Treatment group)

ACTIVE COMPARATOR

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

Group 2 (Control group)

ACTIVE COMPARATOR

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

Interventions

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)

Group 1 (Treatment group)

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

patients will receive BCAA enriched solution (Aminoleban)

Group 2 (Control group)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Liver cirrhosis based on clinical, biochemical, radiological and/or histopathology.
• Patients having overt HE, West Haven criteria (WHC) grade III-IV.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Amino Acids, Branched-Chain; ornithylaspartate

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 14, 2022
• Study Start: September 20, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

EG (1)