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

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2012

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
  • Other: Lactulose
    • Per standard of care

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Hospital Duration/Length of Stay
    • Time Frame: From time of admission to time of discharge or death

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert Rahimi, MD, MSCR, MD, MSCR – University of Texas Southwestern Medical Center
  • Overall Official(s)
    • Robert S Rahimi, MD, MSCR, Principal Investigator, University of Texas Southwestern Medical Center

References

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.

Citations Reporting on Results

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.

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