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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

First Posted
September 7, 2022
Last Updated
October 1, 2023
Sponsor
Ain Shams University
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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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