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

Study Overview
=================
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.

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

Conditions
-----------------
HE, AMS, Hepatic Encephalopathy, Cirrhosis, Altered Mental Status

Intervention / Treatment
-----------------
* Drug: Lactulose
* Drug: Polyethylene Glycol 3350


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lactulose<br>per standard of care | Drug: Lactulose<br>* If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care<br>* Other names: Enulose, Duphalac, generlac, kristalose;|
| Active Comparator: polyethylene glycol 3350 (Golytely)<br> | Drug: Polyethylene Glycol 3350<br>* If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment<br>* Other names: Golytely;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay | To determine if treatment with polyethylene glycol compared to lactulose will reduce the duration of hospital stay | From time of admission to time of discharge an approximate length of seven days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Diseases, cirrhosis, Hepatic Insufficiency, Liver Cirrhosis, Fibrosis, Brain Damage, Chronic, Delirium, Encephalitis, Neurotoxicity Syndromes, Liver Failure, Digestive System Diseases, Brain Diseases, Metabolic, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Metabolic Diseases, Pathologic Processes, Confusion, Neurobehavioral Manifestations, hepatic encephalopathy, hepatic coma, HE, PSE, lactulose, golytely, 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