Expired Study
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Dallas, Texas 75235


Purpose:

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.


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


NCT ID:

NCT01283152


Primary Contact:

Principal Investigator
Robert S Rahimi, MD, MSCR
University of Texas Southwestern Medical Center


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75235
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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