Efficacy of L-Ornithine L-Aspartate in Acute Hepatic Encephalopathy.

NCT01041755 | Completed Phase 4

• 1 other identifier: MI09-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatic encephalopathy is caused by the effects on the brain of substances that under normal circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor responsible for the development of hepatic encephalopathy. In patients with cirrhosis, the reduction in hepatocellular function and generation of portosystemic shunts contribute to increase serum ammonium. The current therapeutic approaches, are aimed at reducing blood ammonium levels. Administration of the non-absorbable disaccharides, have become standard treatment of hepatic encephalopathy.There are no adequate clinical trials comparing the efficacy of L-Ornithine-L-Aspartate (LOLA) infusion against lactose enemas in the treatment of acute hepatic encephalopathy.

Conditions

Hepatic Encephalopathy

Keywords

Encephalopathy; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Improvement of at least one grade in mental state based on the West Haven Criteria

  Improvement was assessed at 0, 24, 48 and 72 hours. The mental state was scored from trivial lack of awareness to deep coma from grade 1 to grade 4.

  72 hours

Secondary Outcomes (7)

• Improvement of at least one grade in mental state assessed by the Glasgow Coma Scale

  72 hours

• Improvement of at least one grade in mental state assessed by the Clinical Hepatic Encephalopathy Staging Scale (CHESS)

  72 hours

• Improvement of asterixis grade

  72 hours

• Improvement in electroencephalographic tracing grade

  72 hours

• Improvement in serum ammonia

  72 hours

Study Arms (2)

Intravenous infusion of L- Ornithine L- Aspartate

EXPERIMENTAL

a) 20 g L-ornithine-L-aspartate

Drug: L-ornithine-L-aspartate

Lactose enemas

ACTIVE COMPARATOR

b) 20% Lactose enemas

Drug: Lactose

Interventions

L-ornithine-L-aspartate DRUG

a) Intravenous infusion of 20 g L-ornithine-L-aspartate (4 ampules of 10 mL each) in 250 mL sodium chloride solution administered daily in 4 hours for 3 consecutive days, plus the placebo b) Water enemas, 1000 mL of water and given as retention enema every 12 hours for 3 consecutive days.

Also known as: LOLA

Intravenous infusion of L- Ornithine L- Aspartate

Lactose DRUG

a) 20% Lactose enemas, 200 g Lactose diluted with 700 mL of water and given as retention enema every 12 hours for 3 consecutive days, plus intravenous placebo b)250 mL sodium chloride solution, infusion for 4 hours for 3 consecutive days.

Lactose enemas

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cirrhosis of any etiology, diagnosed by ultrasound,clinical and / or histologic criteria
• Patients over 18 years and under 75
• Patients with hepatic encephalopathy grade 3-4 according to the criteria of West Haven
• Patients with hyperammonemia \>10 µmol/l

You may not qualify if:

• Evidence of neurological or psychiatric illness
• Use of drugs affecting the central nervous system
• Withdrawal Syndrome
• Anorectal disease that interferes with the administration of enemas

Sponsors & Collaborators

• Centro Regional para el Estudio de las Enfermedades Digestivas: lead
• MERZ PHARMA: collaborator

Study Sites (1)

Hospital Universitario "José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Brain Diseases; Fibrosis

Interventions

ornithylaspartate; Lactose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Francisco J Bosques, MD, PhD

  Centro Regional para el Estudio de las Enfermedades Digestivas

  STUDY DIRECTOR

• Claudia Isabel Blanco Vela, MD

  Hospital Juárez de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 31, 2009
• First Posted: January 1, 2010
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

ME (1)