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
Primary Purpose
Hepatic Encephalopathy
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)
Branched-chain amino acids (BCAA), enriched solution (Aminoleban)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy
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.
Sites / Locations
- Ain-Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 (Treatment group)
Group 2 (Control group)
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05539027
First Posted
September 7, 2022
Last Updated
October 1, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05539027
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (Treatment group)
Arm Type
Active Comparator
Arm Title
Group 2 (Control group)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)
Intervention Description
patients will receive branched-chain amino acids (BCAA), enriched solution (Aminoleban) and L-ornithine L-aspartate (LOLA)
Intervention Type
Drug
Intervention Name(s)
Branched-chain amino acids (BCAA), enriched solution (Aminoleban)
Intervention Description
patients will receive BCAA enriched solution (Aminoleban)
Primary Outcome Measure Information:
Title
Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)
Description
Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)
Time Frame
5 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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