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

NCT ID: NCT05539027

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2024-10-31

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.

Conditions

Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Treatment group)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Group 2 (Control group)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

patients will receive BCAA enriched solution (Aminoleban)

Interventions

Branched-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)

Intervention Type: DRUG

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

patients will receive BCAA enriched solution (Aminoleban)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain-Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 556/ 2022

Identifier Type: -

Identifier Source: org_study_id