drugset / Trial / NCT05539027

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

Phase 4 Completed 140 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-09-20
Primary completion
2024-10-31
Completion
2024-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator L-ornithine L-aspartate Other / unclassified
Comparator Aminoleban Unknown