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

University of Texas Southwestern Medical Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Encephalopathy Cirrhosis Portosystemic Encephalopathy PSE

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ages 18-80 2. Male and female subjects of all races and ethnicities including Spanish speaking subjects 3. Cirrhosis of any cause 4. Any grade of hepatic encephalopathy (1-4) 5. 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: 1. Acute liver failure 2. Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) 3. Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy) 4. Previous use of rifaximin or neomycin in past 7 days 5. Prisoners 6. Pregnancy 7. \<18 years old 8. Serum sodium \<125 mEq/L 9. Receiving \> 1 dose of lactulose prior to enrollment 10. Uncontrolled infection with hemodynamic instability requiring vasopressors

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Baseline to 24 hours

Secondary Outcomes

Hospital Duration/Length of Stay

Time frame: From time of admission to time of discharge or death