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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05539027
Other study ID # FMASU MS 556/ 2022
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 20, 2022
Est. completion date July 15, 2024

Study information

Verified date April 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 1. Mild lack of awareness 2. Lethargic 3. Somnolent but arousable 4. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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)
Branched-chain amino acids (BCAA), enriched solution (Aminoleban)
patients will receive BCAA enriched solution (Aminoleban)

Locations

Country Name City State
Egypt Ain-Shams University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 5 days of treatment
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