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

• Status: Not yet recruiting
• Trial end date: 2023-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: N-Methylaspartate; Pharmaceutical Solutions

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.