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

• Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) (Drug), also known as GoLYTELY® or Miralax®: If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
• Lactulose (Drug): If randomized to this arm, subjects will receive 10-30 grams per standard of care

Primary outcomes

• Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours [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 [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]

Sex: All, ages: 18 Years to 80 Years

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

Participant flow

Outcome results

• Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours (Primary), Number, participants: Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) 21; Lactulose 13
• Hospital Duration/Length of Stay (Secondary), Mean, days: Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) 4 +/- 3; Lactulose 8 +/- 12
• Change in HE Grade at 24 Hours (Primary), Number, participants: Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) 10; Lactulose 9

Adverse events

Serious adverse events by term

• Doran AE, Shah NL. Polyethylene glycol for hepatic encephalopathy: a new solution to purge an old problem? JAMA Intern Med. 2014 Nov;174(11):1734-5. doi: 10.1001/jamainternmed.2014.3501. No abstract available. PMID 25244573
• Results publication: Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamainternmed.2014.4746. PMID 25243839

• Robert S Rahimi, MD, MSCR, Principal investigator, University of Texas Southwestern Medical Center