Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
Completed · Not applicable
Conditions studied: Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
In brief
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.
Key facts
- Study ID
- NCT01283152
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 50
- Starts
- 2011-01-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2014-12-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 18-80
- Male and female subjects of all races and ethnicities including Spanish speaking subjects
- Cirrhosis of any cause
- Any grade of hepatic encephalopathy (1-4)
- 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
You may not qualify if…
- Acute liver failure
- Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
- Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy)
- Previous use of rifaximin or neomycin in past 7 days
- Prisoners
- Pregnancy
- <18 years old
- Serum sodium <125 mEq/L
- Receiving > 1 dose of lactulose prior to enrollment
- Uncontrolled infection with hemodynamic instability requiring vasopressors
Where it is running
- University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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