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

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05539027

Collaborator

(none)

140

Enrollment

Arms

5.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA) Drug: Branched-chain amino acids (BCAA), enriched solution (Aminoleban)	Phase 4

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

Normal
Mild lack of awareness
Lethargic
Somnolent but arousable
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 20, 2022

Anticipated Primary Completion Date :

Mar 20, 2023

Anticipated Study Completion Date :

Mar 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 (Treatment group)	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)
Active Comparator: Group 2 (Control group)	Drug: Branched-chain amino acids (BCAA), enriched solution (Aminoleban) patients will receive BCAA enriched solution (Aminoleban)

Arm

Intervention/Treatment

Active Comparator: Group 1 (Treatment group)

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)

Active Comparator: Group 2 (Control group)

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

patients will receive BCAA enriched solution (Aminoleban)

Outcome Measures

Primary Outcome Measures

Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria) [5 days of treatment]
Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University

ClinicalTrials.gov Identifier:

NCT05539027

Other Study ID Numbers: