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

The University of Texas System (UT)

Status: Completed

Conditions: Hepatic Encephalopathy; Cirrhosis; PSE; Portosystemic Encephalopathy

Treatments: Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®); Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT01283152

072010-121

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

Active Comparator group

Treatment:

Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

Lactulose

Other group

Description:

Per standard of care

Treatment:

Drug: Lactulose