Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •<18 years old
- •Serum sodium <125 mEq/L
- •Receiving > 1 dose of lactulose prior to enrollment
- •Uncontrolled infection with hemodynamic instability requiring vasopressors
Arms & Interventions
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Intervention: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) (Drug)
Lactulose
Per standard of care
Intervention: Lactulose (Drug)
Outcomes
Primary Outcomes
Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours
Time Frame: Baseline to 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
Change in HE Grade at 24 Hours
Time Frame: Baseline to 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
Secondary Outcomes
- Hospital Duration/Length of Stay(From time of admission to time of discharge or death)
Investigators
Robert Rahimi, MD, MSCR
MD, MSCR
University of Texas Southwestern Medical Center