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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Lactulose; Pharmaceutical Solutions; Polyethylene glycol 3350

Criteria

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