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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05539027
• Other study ID #: FMASU MS 556/ 2022
• Status: Recruiting
• Phase: Phase 4
• Start date: September 20, 2022
• Est. completion date: July 15, 2024

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• 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)
• Branched-chain amino acids (BCAA), enriched solution (Aminoleban)
patients will receive BCAA enriched solution (Aminoleban)

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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