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

Primary Purpose

Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Lactulose
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, HE, Cirrhosis, PSE, Portosystemic Encephalopathy, Hepatic coma, AMS, Altered mental status, Complications of cirrhosis, Chronic liver disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)

Lactulose

Arm Description

Per standard of care

Outcomes

Primary Outcome Measures

Number of Participants With an Improvement of 1 or More in HE Grade at 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
Change in HE Grade at 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

Hospital Duration/Length of Stay

Full Information

First Posted
January 24, 2011
Last Updated
December 9, 2014
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01283152
Brief Title
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
Acronym
PSE
Official Title
Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
Keywords
Hepatic Encephalopathy, HE, Cirrhosis, PSE, Portosystemic Encephalopathy, Hepatic coma, AMS, Altered mental status, Complications of cirrhosis, Chronic liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Arm Type
Active Comparator
Arm Title
Lactulose
Arm Type
Other
Arm Description
Per standard of care
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)
Other Intervention Name(s)
GoLYTELY® or Miralax®
Intervention Description
If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
If randomized to this arm, subjects will receive 10-30 grams per standard of care
Primary Outcome Measure Information:
Title
Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours
Description
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
Time Frame
Baseline to 24 hours
Title
Change in HE Grade at 24 Hours
Description
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
Time Frame
Baseline to 24 hours
Secondary Outcome Measure Information:
Title
Hospital Duration/Length of Stay
Time Frame
From time of admission to time of discharge or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Rahimi, MD, MSCR
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center and Parkland Memorial Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25244573
Citation
Doran AE, Shah NL. Polyethylene glycol for hepatic encephalopathy: a new solution to purge an old problem? JAMA Intern Med. 2014 Nov;174(11):1734-5. doi: 10.1001/jamainternmed.2014.3501. No abstract available.
Results Reference
background
PubMed Identifier
25243839
Citation
Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamainternmed.2014.4746.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25243839
Description
PubMed link to abstract

Learn more about this trial

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

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