NCT01283152

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

Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy
• Cirrhosis
• Portosystemic Encephalopathy
• PSE

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-01-25
• Last updated: 2014-12-11
• Results posted: 2014-12-11

Locations

1 site across 1 country: United States