Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.

Study Overview
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Brief Summary
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This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.

Official Title
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Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.

Conditions
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PSE, Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy

Intervention / Treatment
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* Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
* Drug: Lactulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-80 Male and female subjects of all races and ethnicities including Spanish speaking subjects Cirrhosis of any cause Any grade of hepatic encephalopathy (1-4) A legally authorized representative has to be able and 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 subjects behalf Exclusion Criteria: Acute liver failure Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy) Previous use of rifaximin or neomycin in past 7 days Prisoners Pregnancy <18 years old Serum sodium <125 mEq/L Receiving > 1 dose of lactulose prior to enrollment Uncontrolled infection with hemodynamic instability requiring vasopressors

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)<br> | Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)<br>* If randomized to this arm, subjects will receive a 1 time dose of 1 gallon<br>* Other names: GoLYTELY® or Miralax®;|
| Other: Lactulose<br>Per standard of care | Drug: Lactulose<br>* If randomized to this arm, subjects will receive 10-30 grams per standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours | Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA | Baseline to 24 hours | 
| Change in HE Grade at 24 Hours | Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA | Baseline to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Duration/Length of Stay |  | From time of admission to time of discharge or death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HE, Hepatic Encephalopathy, Cirrhosis, PSE, Portosystemic Encephalopathy, Hepatic coma, AMS, Altered mental status, Complications of cirrhosis, Chronic liver disease