Altered Mental Status, AMS, Cirrhosis, HE, Hepatic Encephalopathy
Conditions
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
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.
Detailed description
Hepatic encephalopathy is the occurrence altered level of consciousness as a result of cirrhosis and liver failure. Main treatment goal for hepatic encephalopathy is to eliminate the precipitating factor and to decrease circulating ammonia level. Current standard for treating HE is treatment with Lactulose. Lactulose are metabolized by colonic bacteria to byproducts which cause catharsis and reduces pH, thereby inhibiting ammonia absorption. However, there is limited evidence available to demonstrate the efficacy. Studies on animal model have suggested that polyethylene glycol 3350-electrolyte solution (GOLYTELY) is effective in clearing gut bacteria and reducing the ammoniagenesis in colon. Recently published study by Robert Rahimi, University of Texas Southwestern Medical Center found that polyethylene glycol is more effective in improving HE over the first 24 hours compared to lactulose and also may reduce duration of hospital stay.
Interventions
DRUGLactulose
If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care
DRUGPolyethylene Glycol 3350
If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment
Sponsors
New York Presbyterian Brooklyn Methodist Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of cognition | 24 hours from the time of enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | From time of admission to time of discharge an approximate length of seven days | To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay |
Countries
United States
Outcome results
None listed