Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)

NCT01923376 | Withdrawn DMC

• 1 other identifier: 401550
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether the use of polyethylene glycol is superior and more safe in treating hepatic encephalopathy compared to lactulose and also to determine if treatment with polyethylene glycol will reduce the duration of hospital stay.

Conditions

Hepatic Encephalopathy; HE; Cirrhosis; Altered Mental Status; AMS

Keywords

hepatic encephalopathy; hepatic coma; HE; PSE; lactulose; golytely; cirrhosis; Hepatic Insufficiency; Liver Cirrhosis; Fibrosis; Brain Damage, Chronic; Delirium; Encephalitis; Neurotoxicity Syndromes; Liver Failure; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Delirium, Dementia, Amnestic, Cognitive Disorders; Mental Disorders; Central Nervous System Viral Diseases; Virus Diseases; Central Nervous System Infections; Poisoning; Substance-Related Disorders; Citric Acid

Outcome Measures

Primary Outcomes (1)

• Improvement of cognition

  Subjects will be evaluated every 24hr from the time of enrollment to assess for improvement of cognition until back to baseline and/or grade 0 based on HESA scare

  24 hours from the time of enrollment

Secondary Outcomes (1)

• Duration of hospital stay

  From time of admission to time of discharge an approximate length of seven days

Study Arms (2)

Lactulose

OTHER

per standard of care

Drug: Lactulose

polyethylene glycol 3350 (Golytely)

ACTIVE COMPARATOR

Drug: Polyethylene Glycol 3350

Interventions

Lactulose DRUG

If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care

Also known as: Enulose, Duphalac, generlac, kristalose

Lactulose

Polyethylene Glycol 3350 DRUG

If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment

Also known as: Miralax, Golytely

polyethylene glycol 3350 (Golytely)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80
• Male and female of all races and ethnicities
• Cirrhosis of any cause
• Any grade of hepatic encephalopathy (1-4)
• Representatives have to be willing to comply with all protocol procedures and to understand, sign and date an informed consent document and authorize access to protected health information on the subject's behalf

You may not qualify if:

• Acute liver failure
• Prisoners
• Structural brain lesions (as indicated by CT and confirmed by neurological exam)
• Other causes of altered mental status
• Previous use of rifaximin or neomycin within last 7 days
• Pregnancy
• Serum Na \<125 MEq/liter
• Receiving more than 1 dose (30 cc) of lactulose prior to enrollment
• Uncontrolled infection with hemodynamic instability requiring vasopressors.

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Fibrosis; Hepatic Insufficiency; Liver Cirrhosis; Brain Damage, Chronic; Delirium; Encephalitis; Neurotoxicity Syndromes; Liver Failure; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Central Nervous System Viral Diseases; Virus Diseases; Central Nervous System Infections; Poisoning; Substance-Related Disorders

Interventions

Lactulose; polyethylene glycol 3350; Golytely

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Neuroinflammatory Diseases; Chemically-Induced Disorders; Infections

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Smruti R Mohanty, MD

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 15, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (1)