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

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ClinicalTrials.gov Identifier: NCT01283152
Recruitment Status : Completed
First Posted : January 25, 2011
Results First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Hepatic Encephalopathy Cirrhosis Portosystemic Encephalopathy PSE Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) Drug: Lactulose

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.
Study Start Date : January 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) Drug: Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
Other Name: GoLYTELY® or Miralax®
Lactulose
Per standard of care
Drug: Lactulose
If randomized to this arm, subjects will receive 10-30 grams per standard of care


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours [ Time Frame: Baseline to 24 hours ]
    Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA

  2. Change in HE Grade at 24 Hours [ Time Frame: Baseline to 24 hours ]
    Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA


Secondary Outcome Measures :
  1. Hospital Duration/Length of Stay [ Time Frame: From time of admission to time of discharge or death ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283152


Locations
United States, Texas
University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert S Rahimi, MD, MSCR University of Texas Southwestern Medical Center
More Information

Additional Information:
Publications:
Responsible Party: Robert Rahimi, MD, MSCR, MD, MSCR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01283152     History of Changes
Other Study ID Numbers: 072010-121
First Posted: January 25, 2011    Key Record Dates
Results First Posted: December 11, 2014
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Robert Rahimi, MD, MSCR, University of Texas Southwestern Medical Center:
Hepatic Encephalopathy
HE
Cirrhosis
PSE
Portosystemic Encephalopathy
Hepatic coma
AMS
Altered mental status
Complications of cirrhosis
Chronic liver disease

Additional relevant MeSH terms:
Hepatic Encephalopathy
Fibrosis
Liver Cirrhosis
Brain Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Pharmaceutical Solutions
Polyethylene glycol 3350
Lactulose
Gastrointestinal Agents
Laxatives